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FDA 510(k)

IN VITRO DIAGNOSTIC TEST

K-Number: K770467 · 1977-04-27

ApplicantHoffmann-La Roche, Inc.
Decision Date1977-04-27
Product Code
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1977-04-27 under 510(k) number K770467. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIAGNOSTIC TEST?

IN VITRO DIAGNOSTIC TEST is a medical device that received FDA 510(k) clearance on 1977-04-27. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K770467.

When did IN VITRO DIAGNOSTIC TEST receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC TEST received FDA 510(k) clearance on 1977-04-27, under 510(k) number K770467.

Who is the listed applicant for IN VITRO DIAGNOSTIC TEST?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Hoffmann-La Roche, Inc. 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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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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