The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Variant Ii Turbo Hemoglobin A1c Program, Hemoglobin Testing System With Cdm 4.0.
| Device ID | K063400 |
| 510k Number | K063400 |
| Device Name: | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Jackie Buckley BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2006-12-01 |
| Summary: | summary |