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FDA 510(k)

TEST, IN-VITRO DIAGNOSTIC

K-Number: K760089 · 1976-07-20

ApplicantHoffmann-La Roche, Inc.
Decision Date1976-07-20
Product Code
DecisionSubstantially Equivalent

Device Summary

TEST, IN-VITRO DIAGNOSTIC 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 1976-07-20 under 510(k) number K760089. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST, IN-VITRO DIAGNOSTIC?

TEST, IN-VITRO DIAGNOSTIC is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K760089.

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

TEST, IN-VITRO DIAGNOSTIC received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760089.

Who is the listed applicant for TEST, IN-VITRO DIAGNOSTIC?

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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