510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972064Substantially Equivalent

Microcon 800Muv, Microcon 400Muv, Microcon Exc-Buv

Biological Controls, Inc., Eatontown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972064 is the FDA 510(k) clearance record for MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV, a class II device, cleared for Biological Controls, Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list 2 510(k) clearances for Biological Controls, Inc., from to . As of , FDA records show no recalls naming K972064.

Clearance record

Decision date
Received
(181 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Biological Controls, Inc. One Industrial Way W., Eatontown NJ
510(k) summary
Statement
Third party review
No

Clearances, product code FRA

Trailing 12 months

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

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