BIOPLEX 2200 TORC IGG— 510(k) K120572

Name: FDA 510(k) clearance K120572
Creator: U.S. Food and Drug Administration
Published: 2012-03-26

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K120572 for BIOPLEX 2200 TORC IGG, Substantially Equivalent on 2012-03-26. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code OMI
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 2012-02-27
Decision date: 2012-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Benicia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMI

view all

K080008 — BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET2009-02-23

More clearances from Bio-Rad Laboratories, Inc.

view all

K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System2019-02-13
K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software2017-09-13
K161687 — D-10 Hemoglobin A1c Program2016-10-14
K151321 — D-100 HbA1c, D-100 HbA1c Calibrator Pack2015-12-09
K142448 — VARIANT II TURBO HbA1c Kit - 2.02015-03-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.