The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Pt.
| Device ID | K991065 |
| 510k Number | K991065 |
| Device Name: | CARESIDE PT |
| Classification | Test, Time, Prothrombin |
| Applicant | CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Contact | Nenneth B Asarch |
| Correspondent | Nenneth B Asarch CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-07-26 |
| Summary: | summary |