JLB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Atp And Creatine Kinase (Enzymatic), Creatine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1210
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1996: 1 · 2001: 1 · 2011: 50 · 2012: 73 · 2013: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PICCOLO METLYTE 7 REAGENT DISC (K992140) | Abaxis, Inc. | 1999-08-26 |
| OLYMPUS CK-MB REAGENT (K971817) | Olympus America, Inc. | 1997-06-11 |
| UNITEST CREATINE KINASE (K782156) | Boehringer Mannheim Corp. | 1979-03-02 |
Track JLB automatically
Every clearance here is in the API, with alerts when new ones post.