CARESIDE ANALYZER
Enzymatic Esterase--oxidase, Cholesterol
EXIGENT DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Exigent Diagnostics, Inc. with the FDA for Careside Analyzer.
Pre-market Notification Details
| Device ID | K982118 |
| 510k Number | K982118 |
| Device Name: | CARESIDE ANALYZER |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| 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 | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-03 |
| Decision Date | 1998-07-24 |
| Summary: | summary |
Trademark Results [CARESIDE ANALYZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARESIDE ANALYZER 75298942 2375634 Dead/Cancelled |
CARESIDE, INC. 1997-05-27 |
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