Device Classification Name |
Radioimmunoassay (Two-Site Solid Phase), Ferritin
|
510(k) Number |
K963498 |
Device Name |
FERR FLEX REAGENT CARTRIDGE |
Applicant |
DADE CHEMISTRY SYSTEMS, INC. |
P.O. BOX 6101, GLASGOW BLDG |
500 MAILBOX 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
CATHY P CRAFT |
Correspondent |
DADE CHEMISTRY SYSTEMS, INC. |
P.O. BOX 6101, GLASGOW BLDG |
500 MAILBOX 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
CATHY P CRAFT |
Regulation Number | 866.5340
|
Classification Product Code |
|
Date Received | 09/03/1996 |
Decision Date | 01/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|