FDA Product Code
FDA Product Code JLB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1210
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K992140 | PICCOLO METLYTE 7 REAGENT DISC | Abaxis, Inc. | 1999-08-26 | Traditional | PDF ↗ |
| K971817 | OLYMPUS CK-MB REAGENT | Olympus America, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K782156 | UNITEST CREATINE KINASE | Boehringer Mannheim Corp. | 1979-03-02 | Traditional | PDF ↗ |
Product code JLB · Class I · Clinical Chemistry. Data: openFDA.