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FDA 510(k)

QUANTIMUNE HFSH RIA

K-Number: K791836 · 1979-10-01

ApplicantBio-Rad
Decision Date1979-10-01
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE HFSH RIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1979-10-01 under 510(k) number K791836. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMUNE HFSH RIA?

QUANTIMUNE HFSH RIA is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Bio-Rad. The 510(k) number is K791836.

When did QUANTIMUNE HFSH RIA receive FDA 510(k) clearance?

QUANTIMUNE HFSH RIA received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791836.

Who is the listed applicant for QUANTIMUNE HFSH RIA?

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 HFSH RIA?

The FDA product code for QUANTIMUNE HFSH RIA is CGJ.

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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.

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Related Devices (Code: CGJ)

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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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