The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Hemoglobin.
| Device ID | K001462 |
| 510k Number | K001462 |
| Device Name: | CARESIDE HEMOGLOBIN |
| Classification | Whole Blood Hemoglobin Determination |
| 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 | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-10 |
| Decision Date | 2000-08-21 |