The following data is part of a premarket notification filed by Exigent Diagnostics, Inc. with the FDA for Careside Creatinine.
| Device ID | K980043 |
| 510k Number | K980043 |
| Device Name: | CARESIDE CREATININE |
| Classification | Enzymatic Method, Creatinine |
| Applicant | EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-06 |
| Decision Date | 1998-03-30 |
| Summary: | summary |