510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811067Substantially Equivalent

Bio-Bag Tm Environmental Chamber Type M

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

K811067 is the FDA 510(k) clearance record for BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M, a class II device, cleared for Marion Laboratories, Inc. on under FDA product code KZT (Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin). FDA records list 38 510(k) clearances for Marion Laboratories, Inc., from to . As of , FDA records show no recalls naming K811067.

Clearance record

Decision date
Received
(12 days to decision)
Product code
KZT Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Marion Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZT

Trailing 12 months

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

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