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FDA 510(k)

QUANTIMUNE T-3 FIA

K-Number: K790960 · 1979-08-10

ApplicantBio-Rad
Decision Date1979-08-10
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE T-3 FIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K790960. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMUNE T-3 FIA?

QUANTIMUNE T-3 FIA is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Bio-Rad. The 510(k) number is K790960.

When did QUANTIMUNE T-3 FIA receive FDA 510(k) clearance?

QUANTIMUNE T-3 FIA received FDA 510(k) clearance on 1979-08-10, under 510(k) number K790960.

Who is the listed applicant for QUANTIMUNE T-3 FIA?

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 QUANTIMUNE T-3 FIA?

The FDA product code for QUANTIMUNE T-3 FIA is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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