510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770833Substantially Equivalent

Fluoretec-M

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

K770833 is the FDA 510(k) clearance record for FLUORETEC-M, a class I device, cleared for Pfizer, Inc. on under FDA product code GMY (Antisera, Fluorescent, All Types, Escherichia Coli). FDA records list 30 510(k) clearances for Pfizer, Inc., from to . As of , FDA records show no recalls naming K770833.

Clearance record

Decision date
Received
(33 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, Inc. 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