510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K792654Substantially Equivalent

Culturette Brand-Pva/formalin Kit

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

K792654 is the FDA 510(k) clearance record for CULTURETTE BRAND-PVA/FORMALIN KIT, a class I device, cleared for Marion Laboratories, Inc. on under FDA product code IFQ (Formulations, Mercuric Chloride For Tissue). FDA records list 38 510(k) clearances for Marion Laboratories, Inc., from to . As of , FDA records show no recalls naming K792654.

Clearance record

Decision date
Received
(29 days to decision)
Product code
IFQ Formulations, Mercuric Chloride For Tissue
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Marion Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IFQ

Trailing 12 months

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

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