VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
FDA 510(k) clearance K070819 · decided 2007-06-25
Clearance details
- K-number
- K070819
- Device name
- VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Decision
- Substantially Equivalent
- Date received
- 2007-03-26
- Decision date
- 2007-06-25
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determinatio recall (Z-0399-2012) | Bio-Rad Laboratories, Inc. | 2012-01-11 |
| VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad La recall (Z-0026-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the determinati recall (Z-0027-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Ki recall (Z-3159-2011) | Bio-Rad Laboratories, Inc. | 2011-09-06 |
| Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program R recall (Z-1259-2011) | Bio-Rad Laboratories Inc | 2011-02-15 |