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FDA 510(k)

QUANTIMUNE HTSH IRMA HUMAN THYROID

K-Number: K781170 · 1978-08-14

ApplicantBio-Rad
Decision Date1978-08-14
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE HTSH IRMA HUMAN THYROID is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781170. 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 HUMAN THYROID?

QUANTIMUNE HTSH IRMA HUMAN THYROID is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Bio-Rad. The 510(k) number is K781170.

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

QUANTIMUNE HTSH IRMA HUMAN THYROID received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781170.

Who is the listed applicant for QUANTIMUNE HTSH IRMA HUMAN THYROID?

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 HUMAN THYROID?

The FDA product code for QUANTIMUNE HTSH IRMA HUMAN THYROID 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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