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
K820137Substantially Equivalent

Immu-Count

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

K820137 is the FDA 510(k) clearance record for IMMU-COUNT, a class I device, cleared for Kemble Instruments, Inc. on under FDA product code JJJ (Counter (Beta, Gamma) For Clinical Use). FDA records list 9 510(k) clearances for Kemble Instruments, Inc., from to . As of , FDA records show no recalls naming K820137.

Clearance record

Decision date
Received
(18 days to decision)
Product code
JJJ Counter (Beta, Gamma) For Clinical Use
Regulation
21 CFR 862.2320
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Kemble Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJJ

Trailing 12 months

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

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