JLB — Atp And Creatine Kinase (Enzymatic), Creatine Class I
FDA Device Classification
Classification Details
- Product Code
- JLB
- Device Class
- Class I
- Regulation Number
- 862.1210
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K992140 | abaxis | PICCOLO METLYTE 7 REAGENT DISC | August 26, 1999 |
| K971817 | olympus america | OLYMPUS CK-MB REAGENT | June 11, 1997 |
| K782156 | boehringer mannheim | UNITEST CREATINE KINASE | March 2, 1979 |