VARIANT II TURBO HbA1c Kit - 2.0— 510(k) K142448
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K142448 for VARIANT II TURBO HbA1c Kit - 2.0, Substantially Equivalent on 2015-03-24. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code PDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1373
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hercules, CA, US
Recent devices under product code PDJ
view allMore clearances from Bio-Rad Laboratories, Inc.
view all- K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
- K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
- K161687 — D-10 Hemoglobin A1c Program
- K151321 — D-100 HbA1c, D-100 HbA1c Calibrator Pack
- K140801 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.