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
K855237Substantially Equivalent

Biotel (Tm)/ Kidney

American Diagnostic Corp., Wheaton IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855237 is the FDA 510(k) clearance record for BIOTEL (TM)/ KIDNEY, a class II device, cleared for American Diagnostic Corp. on under FDA product code KHE (Reagent, Occult Blood). FDA records list 39 510(k) clearances for American Diagnostic Corp., from to . As of , FDA records show no recalls naming K855237.

Clearance record

Decision date
Received
(126 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
American Diagnostic Corp. P.O. Box 89, Wheaton IL
Third party review
No

Clearances, product code KHE

Trailing 12 months

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

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