The following data is part of a premarket notification filed by Bio-rad Laboratories Inc., Clinical Systems Divisi with the FDA for Variant Ii Turbo Link Hemoglobin A1c Program, And Variant Ii Turbo Link Hemoglobin Testing With Model, 270-2716,.
| Device ID | K070819 |
| 510k Number | K070819 |
| Device Name: | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie H Buckley |
| Correspondent | Jackie H 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817014901 | K070819 | 000 |
| 00847817014895 | K070819 | 000 |
| 00847817014888 | K070819 | 000 |
| 00847817014871 | K070819 | 000 |
| 00847817014833 | K070819 | 000 |
| 00847817008580 | K070819 | 000 |
| 00847817000119 | K070819 | 000 |
| 00847817000010 | K070819 | 000 |
| 00847817000003 | K070819 | 000 |