The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Ammonia.
| Device ID | K991371 |
| 510k Number | K991371 |
| Device Name: | CARESIDE AMMONIA |
| Classification | Photometric Method, Ammonia |
| Applicant | CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Contact | Kenneth B Assarch, Pharm |
| Correspondent | Kenneth B Assarch, Pharm CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Product Code | JID |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-20 |
| Decision Date | 1999-08-03 |
| Summary: | summary |