The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Lytes, Careside Anallyzer Model 1000.
| Device ID | K990036 |
| 510k Number | K990036 |
| Device Name: | CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 1999-03-18 |
| Summary: | summary |