Device Classification Name |
atp and creatine kinase (enzymatic), creatine
|
510(k) Number |
K992140 |
Device Name |
PICCOLO METLYTE 7 REAGENT DISC |
Applicant |
ABAXIS, INC. |
1320 CHESAPEAKE TERRACE |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
LISA MCGRATH |
Correspondent |
ABAXIS, INC. |
1320 CHESAPEAKE TERRACE |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
LISA MCGRATH |
Regulation Number | 862.1210
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/24/1999 |
Decision Date | 08/26/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|