510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123805Substantially Equivalent

E-Z Chek Blood Leak Test Strips

Reprocessing Products Corp, Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123805 is the FDA 510(k) clearance record for E-Z CHEK BLOOD LEAK TEST STRIPS, a class II device, cleared for Reprocessing Products Corp on under FDA product code FJD (Detector, Leak, Blood). FDA records list 6 510(k) clearances for Reprocessing Products Corp, from to . As of , FDA records show no recalls naming K123805.

Clearance record

Decision date
Received
(99 days to decision)
Product code
FJD Detector, Leak, Blood
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Reprocessing Products Corp P.O. Box 35849, Tucson AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FJD

Trailing 12 months

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

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