510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K842086Substantially Equivalent

Spottest Lactophenol Cotton Blue Stain

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

K842086 is the FDA 510(k) clearance record for SPOTTEST LACTOPHENOL COTTON BLUE STAIN, a class I device, cleared for Difco Laboratories, Inc. on under FDA product code JTO (Discs, Strips And Reagents, Microorganism Differentiation). FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show one recall naming K842086.

Clearance record

Decision date
Received
(40 days to decision)
Product code
JTO Discs, Strips And Reagents, Microorganism Differentiation
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Difco Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTO

Trailing 12 months

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

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