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
K850194Substantially Equivalent

Caffeic Acid Disk

Remel Inc, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850194 is the FDA 510(k) clearance record for CAFFEIC ACID DISK, a class I device, cleared for Remel Co. on under FDA product code JSF (Culture Media, Single Biochemical Test). FDA records list 107 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K850194.

Clearance record

Decision date
Received
(94 days to decision)
Product code
JSF Culture Media, Single Biochemical Test
Regulation
21 CFR 866.2320
Device class
Class I
Review panel
Microbiology
Applicant
Remel Co. 12076 Santa Fe Dr., Lenexa KS
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