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FDA 510(k)

MICROBIO. PROD. FLUORESCENT ANTIBODY

K-Number: K770801 · 1977-05-25

ApplicantPfizer Pharmaceuticals
Decision Date1977-05-25
Product CodeGMY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROBIO. PROD. FLUORESCENT ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Pharmaceuticals. It received FDA 510(k) clearance on 1977-05-25 under 510(k) number K770801. The device is classified under product code GMY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROBIO. PROD. FLUORESCENT ANTIBODY?

MICROBIO. PROD. FLUORESCENT ANTIBODY is a medical device that received FDA 510(k) clearance on 1977-05-25. The listed applicant is Pfizer Pharmaceuticals. The 510(k) number is K770801.

When did MICROBIO. PROD. FLUORESCENT ANTIBODY receive FDA 510(k) clearance?

MICROBIO. PROD. FLUORESCENT ANTIBODY received FDA 510(k) clearance on 1977-05-25, under 510(k) number K770801.

Who is the listed applicant for MICROBIO. PROD. FLUORESCENT ANTIBODY?

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

What is the FDA product code for MICROBIO. PROD. FLUORESCENT ANTIBODY?

The FDA product code for MICROBIO. PROD. FLUORESCENT ANTIBODY is GMY.

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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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Other records listing Pfizer Pharmaceuticals 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.

K885321WATER JEL STERILE GEL-SOAKED BURN DRESSINGK810427CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.K802408E-VAC BLOOD CULTURE SYSTEMK771605CREATINE KINASE ISOENZYME SUBSTRATE SETK770425NEEDLES, STERILE, AIRWAY

Related Devices (Code: GMY)

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.

K770833FLUORETEC-MPfizer, Inc.

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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