The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Variant Ii Hemoglobin A1c Program With Models 270-2101nu.
| Device ID | K070452 |
| 510k Number | K070452 |
| Device Name: | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules, CA 94547 |
| Contact | Jackie H Buckley |
| Correspondent | Jackie H 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817014185 | K070452 | 000 |
| 00847817011979 | K070452 | 000 |
| 00847817011955 | K070452 | 000 |
| 00847817011948 | K070452 | 000 |
| 00847817011931 | K070452 | 000 |
| 00847817011924 | K070452 | 000 |
| 00847817010606 | K070452 | 000 |
| 00847817000324 | K070452 | 000 |