The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Metlyte 7 Reagent Disc.
| Device ID | K992140 |
| 510k Number | K992140 |
| Device Name: | PICCOLO METLYTE 7 REAGENT DISC |
| Classification | Atp And Creatine Kinase (enzymatic), Creatine |
| Applicant | ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | JLB |
| Subsequent Product Code | CEM |
| Subsequent Product Code | KHS |
| CFR Regulation Number | 862.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-24 |
| Decision Date | 1999-08-26 |
| Summary: | summary |