|
Device |
indicator, biological sterilization process |
Product Code | FRC |
Regulation Number |
880.2800
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
21
|
3M COMPANY-3M HEALTH CARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3M COMPLANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED STERILIZATION PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
1. K092755 STERRAAD 100NX EXPRESS CYCLE TEST PACK
|
2. K102884 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
|
3. K103222 STERRAD CYCLESURE BIOLOGICAL INDICATOR
|
4. K111375 STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
|
5. K111391 STERRAD (R) 100NX DUO CYCLE TEST PACK
|
6. K122044 STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
|
7. K123017 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14 ...
|
8. K130263 STERRAD 50/100S/200 TEST PACK
|
9. K151971 STERRAD CYCLESURE 24 Biological Indicator
|
ADVANCED STERILIZATION PRODUCTS (ASP) |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANDERSEN STERILIZERS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ANDERSEN STERILIZERS,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BCR DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSTEX INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSTEX/SPSMEDICAL, A DIVISION OF CANTEL MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DANA PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GKE-GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MESA LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NORTH AMERICAN SCIENCE ASSOC., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PLASMAPP CO,.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLASMAPP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAVEN BIOLOGICAL LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SGM BIOTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPS MEDICAL SUPPLY CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPSMEDICAL SUPPLY CORP. A DIVISION OF CANTEL MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERILUCENT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STERILUCENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
28
|
STERIS CORPORATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STERITEC PRODUCTS MFG. CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERITEC PRODUCTS MFG., CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TERRAGENE SA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TRUE INDICATING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TSO3 INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TSO3 INC., NOW A PART OF STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|