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FDA 510(k)

QUANTIGEN T & B CELL ASSAY

K-Number: K831053 · 1983-08-08

ApplicantBio-Rad
Decision Date1983-08-08
Product CodeLIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUANTIGEN T & B CELL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1983-08-08 under 510(k) number K831053. The device is classified under product code LIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIGEN T & B CELL ASSAY?

QUANTIGEN T & B CELL ASSAY is a medical device that received FDA 510(k) clearance on 1983-08-08. The listed applicant is Bio-Rad. The 510(k) number is K831053.

When did QUANTIGEN T & B CELL ASSAY receive FDA 510(k) clearance?

QUANTIGEN T & B CELL ASSAY received FDA 510(k) clearance on 1983-08-08, under 510(k) number K831053.

Who is the listed applicant for QUANTIGEN T & B CELL ASSAY?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIGEN T & B CELL ASSAY?

The FDA product code for QUANTIGEN T & B CELL ASSAY is LIZ.

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Other records listing Bio-Rad as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: LIZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K914847CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.K860830TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHODTechnicon Instruments Corp.K843062TBM-REAGENT FOR T,B CELL & MONOCYTESBd Becton Dickinson Vacutainer Systems PreanalyticK842218ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems PreanalyticK833929WHITE BLOOD CELLS HUMAN TAND BControl DiagnosticsK820643ORTHO SPECTRUM III & ORTHO-MUNE OKOrtho Diagnostic Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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