510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920761Substantially Equivalent

Urine Cultur Stabilization Transport Tube

Bio Medicus, Inc., Rockaway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920761 is the FDA 510(k) clearance record for URINE CULTUR STABILIZATION TRANSPORT TUBE, a class I device, cleared for Bio Medicus, Inc. on under FDA product code LIO (Device, Specimen Collection). FDA records list 15 510(k) clearances for Bio Medicus, Inc., from to . As of , FDA records show no recalls naming K920761.

Clearance record

Decision date
Received
(121 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Bio Medicus, Inc. 50 White Meadow Rd., Rockaway NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LIO

Trailing 12 months

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

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