Panels › Clinical Chemistry › Product code JLB · Class 1
Atp And Creatine Kinase (Enzymatic), Creatine
Regulation 862.1210
0510(k)s in 12 months (3 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JLB
| Company | 510(k)s | Recalls |
|---|---|---|
| Abaxis, Inc. | 1 | 2 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Olympus America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 1999 | K992140 | PICCOLO METLYTE 7 REAGENT DISC Abaxis, Inc. | JLB |
| Jun 11, 1997 | K971817 | OLYMPUS CK-MB REAGENT Olympus America, Inc. | JLB |
| Mar 2, 1979 | K782156 | UNITEST CREATINE KINASE Boehringer Mannheim Corp. | JLB |
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