The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Analyzer.
| Device ID | K993634 | 
| 510k Number | K993634 | 
| Device Name: | CARESIDE ANALYZER | 
| Classification | Analyzer, Chemistry, Micro, For Clinical Use | 
| 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 | JJF | 
| CFR Regulation Number | 862.2170 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1999-10-27 | 
| Decision Date | 1999-12-02 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CARESIDE ANALYZER  75298942  2375634 Dead/Cancelled | CARESIDE, INC. 1997-05-27 |