Panels › Clinical Chemistry › Product code JJT · Class 1
Enzyme Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (97 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 7 | 0 |
| Bio-Rad | 6 | 0 |
| Cala Diagnostics | 6 | 0 |
| Dade, Baxter Travenol Diagnostics, Inc. | 4 | 0 |
| Helena Laboratories | 4 | 0 |
| Clinical Controls, Inc. | 3 | 0 |
| Medical Analysis Systems, Inc. | 3 | 0 |
| Nyegaard & Co. A/S | 3 | 0 |
| Quantimetrix Corp. | 3 | 0 |
| Specialized Assays, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2012 | Abbott Point Of Care Inc. Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number Terminated |
JJT | K030768 |
| May 29, 2003 | PerkinElmer LIfe Sciences Inc Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100. Terminated |
JJT | K950803 |
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