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FDA 510(k)

QUANTIMUNE HLH RIA

K-Number: K821346 · 1982-05-28

ApplicantBio-Rad
Decision Date1982-05-28
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE HLH 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 1982-05-28 under 510(k) number K821346. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMUNE HLH RIA?

QUANTIMUNE HLH RIA is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is Bio-Rad. The 510(k) number is K821346.

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

QUANTIMUNE HLH RIA received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821346.

Who is the listed applicant for QUANTIMUNE HLH 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 HLH RIA?

The FDA product code for QUANTIMUNE HLH RIA is CEP.

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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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