The following data is part of a premarket notification filed by Bio-rad Laboratories Inc., Clinical Systems Divisi with the FDA for Modification To Variant Ii: Hemoglobin A1c Program, Beta-thalassemia Short Program And Total Ghb Program.
| Device ID | K063643 |
| 510k Number | K063643 |
| Device Name: | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Jackie Buckley BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 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 | 2006-12-07 |
| Decision Date | 2006-12-27 |
| Summary: | summary |