510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833917Substantially Equivalent

Bac-T-Screen

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

K833917 is the FDA 510(k) clearance record for BAC-T-SCREEN, a class I device, cleared for Marion Laboratories, Inc. on under FDA product code JTA (Monitor, Microbial Growth). FDA records list 38 510(k) clearances for Marion Laboratories, Inc., from to . As of , FDA records show no recalls naming K833917.

Clearance record

Decision date
Received
(60 days to decision)
Product code
JTA Monitor, Microbial Growth
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Applicant
Marion Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTA

Trailing 12 months

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

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