The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc., Clinical Systems Divis with the FDA for Variant Ii Turbo Hba1c Kit-2.0 Variant Ii Turbo Hemoglobin Testing System.
| Device ID | K122472 |
| 510k Number | K122472 |
| Device Name: | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Jackie Buckley BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules, CA 94547 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-14 |
| Decision Date | 2012-10-26 |
| Summary: | summary |