510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770801Substantially Equivalent

Microbio. Prod. Fluorescent Antibody

Pfizer Pharmaceuticals, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770801 is the FDA 510(k) clearance record for MICROBIO. PROD. FLUORESCENT ANTIBODY, a class I device, cleared for Pfizer Pharmaceuticals on under FDA product code GMY (Antisera, Fluorescent, All Types, Escherichia Coli). FDA records list 6 510(k) clearances for Pfizer Pharmaceuticals, from to . As of , FDA records show no recalls naming K770801.

Clearance record

Decision date
Received
(23 days to decision)
Product code
GMY Antisera, Fluorescent, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
Device class
Class I
Review panel
Microbiology
Applicant
Pfizer Pharmaceuticals 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GMY

Trailing 12 months

FDA records hold no clearances under product code GMY in the trailing twelve months.

FDA records show no clearances under product code GMY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GMY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260