510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K843364Substantially Equivalent

Differentiation Disks Bile Esculin

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

K843364 is the FDA 510(k) clearance record for DIFFERENTIATION DISKS BILE ESCULIN, a class I device, cleared for Difco Laboratories, Inc. on under FDA product code JSF (Culture Media, Single Biochemical Test). FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show no recalls naming K843364.

Clearance record

Decision date
Received
(10 days to decision)
Product code
JSF Culture Media, Single Biochemical Test
Regulation
21 CFR 866.2320
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 JSF

Trailing 12 months

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

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