The following data is part of a premarket notification filed by Bio-rad with the FDA for Variant Express Glycohemoglobin Program.
| Device ID | K972609 |
| 510k Number | K972609 |
| Device Name: | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | John W Nelson |
| Correspondent | John W Nelson BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | LCQ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1997-08-06 |
| Summary: | summary |