K853454Substantially Equivalent

Sure Count 5 & 10 Sponge Counter

Name: K853454 Sure Count 5 & 10 Sponge Counter
Creator: Kleen Test Products
Published: 1985-09-05
License: https://open.fda.gov/license/

Kleen Test Products Corporation, Milwaukee WI / Traditional, Substantially Equivalent

FDA source

K853454 is the FDA 510(k) clearance record for SURE COUNT 5 & 10 SPONGE COUNTER, cleared for Kleen Test Products on 1985-09-05. FDA records list 17 510(k) clearances for Kleen Test Products, from 1976-11-02 to 1989-10-24. As of 2026-09-10, FDA records show no recalls naming K853454.

Clearance record

Decision date: 1985-09-05
Received: 1985-08-16 (20 days to decision)
Review panel: Unknown
Applicant: Kleen Test Products 4425 W. Woolworth Ave., Milwaukee WI
Third party review: No