510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851399Substantially Equivalent

Bac-T-Screen

Marion Laboratories, Inc., Kansas City MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851399 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 JXA (Kit, Screening, Urine). FDA records list 38 510(k) clearances for Marion Laboratories, Inc., from to . As of , FDA records show no recalls naming K851399.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JXA Kit, Screening, Urine
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Marion Laboratories, Inc. P.O. Box 9627, Kansas City MI
Third party review
No

Clearances, product code JXA

Trailing 12 months

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

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