510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781388Substantially Equivalent

F.a. Mounting Medium

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

K781388 is the FDA 510(k) clearance record for F.A. MOUNTING MEDIUM, a class I device, cleared for Flow Laboratories, Inc. on under FDA product code KEQ (Media, Mounting, Water Soluble). FDA records list 57 510(k) clearances for Flow Laboratories, Inc., from to . As of , FDA records show no recalls naming K781388.

Clearance record

Decision date
Received
(11 days to decision)
Product code
KEQ Media, Mounting, Water Soluble
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Flow Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KEQ

Trailing 12 months

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

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