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FDA 510(k)

QUANTIMUNE HTSH IRMA

K-Number: K822291 · 1982-08-27

ApplicantBio-Rad
Decision Date1982-08-27
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE HTSH IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K822291. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMUNE HTSH IRMA?

QUANTIMUNE HTSH IRMA is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Bio-Rad. The 510(k) number is K822291.

When did QUANTIMUNE HTSH IRMA receive FDA 510(k) clearance?

QUANTIMUNE HTSH IRMA received FDA 510(k) clearance on 1982-08-27, under 510(k) number K822291.

Who is the listed applicant for QUANTIMUNE HTSH IRMA?

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 HTSH IRMA?

The FDA product code for QUANTIMUNE HTSH IRMA is JLW.

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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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