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FDA 510(k)

AGGLUTINATING SERUM W135

K-Number: K771562 · 1977-08-25

ApplicantBurroughs Wellcome Co.
Decision Date1977-08-25
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AGGLUTINATING SERUM W135 is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1977-08-25 under 510(k) number K771562. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGGLUTINATING SERUM W135?

AGGLUTINATING SERUM W135 is a medical device that received FDA 510(k) clearance on 1977-08-25. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K771562.

When did AGGLUTINATING SERUM W135 receive FDA 510(k) clearance?

AGGLUTINATING SERUM W135 received FDA 510(k) clearance on 1977-08-25, under 510(k) number K771562.

Who is the listed applicant for AGGLUTINATING SERUM W135?

The FDA 510(k) record lists Burroughs Wellcome Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGGLUTINATING SERUM W135?

The FDA product code for AGGLUTINATING SERUM W135 is GTJ.

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Other records listing Burroughs Wellcome Co. as applicant

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Related Devices (Code: GTJ)

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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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