510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K822954Substantially Equivalent

Microtech Bacterial Controls

Universal Micro Reference Laboratory, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822954 is the FDA 510(k) clearance record for MICROTECH BACTERIAL CONTROLS, a class I device, cleared for Universal Micro Reference Laboratory on under FDA product code JTR (Kit, Quality Control For Culture Media). FDA records list one 510(k) clearance for Universal Micro Reference Laboratory. As of , FDA records show no recalls naming K822954.

Clearance record

Decision date
Received
(43 days to decision)
Product code
JTR Kit, Quality Control For Culture Media
Regulation
21 CFR 866.2480
Device class
Class I
Review panel
Microbiology
Applicant
Universal Micro Reference Laboratory 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTR

Trailing 12 months

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

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