K992140 is an FDA 510(k) clearance for the PICCOLO METLYTE 7 REAGENT DISC. This device is classified as a Atp And Creatine Kinase (enzymatic), Creatine (Class I - General Controls, product code JLB).
Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 26, 1999, 63 days after receiving the submission on June 24, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1210.
| 510(k) Number | K992140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1999 |
| Decision Date | August 26, 1999 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JLB — Atp And Creatine Kinase (enzymatic), Creatine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1210 |