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FDA 510(k)

FLUORETEC-M

K-Number: K770833 · 1977-06-08

ApplicantPfizer, Inc.
Decision Date1977-06-08
Product CodeGMY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUORETEC-M is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1977-06-08 under 510(k) number K770833. 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 FLUORETEC-M?

FLUORETEC-M is a medical device that received FDA 510(k) clearance on 1977-06-08. The listed applicant is Pfizer, Inc.. The 510(k) number is K770833.

When did FLUORETEC-M receive FDA 510(k) clearance?

FLUORETEC-M received FDA 510(k) clearance on 1977-06-08, under 510(k) number K770833.

Who is the listed applicant for FLUORETEC-M?

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

What is the FDA product code for FLUORETEC-M?

The FDA product code for FLUORETEC-M is GMY.

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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.

K770801MICROBIO. PROD. FLUORESCENT ANTIBODYPfizer Pharmaceuticals

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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