The following data is part of a premarket notification filed by Careside Hemotology, Inc. with the FDA for Careside Aptt.
| Device ID | K014028 |
| 510k Number | K014028 |
| Device Name: | CARESIDE APTT |
| Classification | Activated Partial Thromboplastin |
| Applicant | CARESIDE HEMOTOLOGY, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch CARESIDE HEMOTOLOGY, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-06 |
| Decision Date | 2002-02-08 |
| Summary: | summary |