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FDA 510(k)

STREP B POLYVALENT FLUORO-KIT

K-Number: K801876 · 1980-09-16

ApplicantClinical Sciences, Inc.
Decision Date1980-09-16
Product CodeGTX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREP B POLYVALENT FLUORO-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801876. The device is classified under product code GTX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREP B POLYVALENT FLUORO-KIT?

STREP B POLYVALENT FLUORO-KIT is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K801876.

When did STREP B POLYVALENT FLUORO-KIT receive FDA 510(k) clearance?

STREP B POLYVALENT FLUORO-KIT received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801876.

Who is the listed applicant for STREP B POLYVALENT FLUORO-KIT?

The FDA 510(k) record lists Clinical Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STREP B POLYVALENT FLUORO-KIT?

The FDA product code for STREP B POLYVALENT FLUORO-KIT is GTX.

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Related Devices (Code: GTX)

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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