510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875367Substantially Equivalent

Colorgene Fluorescent DNA Hybridization Test / Cmv

Enzo Biochem, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875367 is the FDA 510(k) clearance record for COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV, a class II device, cleared for Enzo Biochem, Inc. on under FDA product code GQM (Antisera, Neutralization, Herpesvirus Hominis). FDA records list 5 510(k) clearances for Enzo Biochem, Inc., from to . As of , FDA records show no recalls naming K875367.

Clearance record

Decision date
Received
(88 days to decision)
Product code
GQM Antisera, Neutralization, Herpesvirus Hominis
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Enzo Biochem, Inc. 325 Hudson St., New York NY
Third party review
No

Clearances, product code GQM

Trailing 12 months

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

FDA records show no clearances under product code GQM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GQM, 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