The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Variant Ii Hemoglobin A1c.
| Device ID | K040872 |
| 510k Number | K040872 |
| Device Name: | VARIANT II HEMOGLOBIN A1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES 1500 CAPITOL AVENUE MAILSTOP 7602 Sacramento, CA 95814 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817014154 | K040872 | 000 |
| 00847817000416 | K040872 | 000 |
| 00847817000461 | K040872 | 000 |
| 00847817010613 | K040872 | 000 |
| 00847817013904 | K040872 | 000 |
| 00847817013928 | K040872 | 000 |
| 00847817013966 | K040872 | 000 |
| 00847817014079 | K040872 | 000 |
| 00847817014093 | K040872 | 000 |
| 00847817000409 | K040872 | 000 |