510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K760838Substantially Equivalent

Lacto-Phenol Cotton Blue Mounting Fl.

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

K760838 is the FDA 510(k) clearance record for LACTO-PHENOL COTTON BLUE MOUNTING FL., a class I device, cleared for I M, Inc. on under FDA product code LEB (Mounting Media). FDA records list 26 510(k) clearances for I M, Inc., from to . As of , FDA records show no recalls naming K760838.

Clearance record

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

Clearances, product code LEB

Trailing 12 months

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

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