510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101750Substantially Equivalent

Rpc E-Z Chek 6.8-8.5 Ph Test Strips, Model K100-0117 and E-Z Chek 0-14 Ph Test Strips, Model K100-0104

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

K101750 is the FDA 510(k) clearance record for RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104, a class II device, cleared for Reprocessing Products Corp on under FDA product code MNV (Strip, Dialysate Ph Indicator). FDA records list 6 510(k) clearances for Reprocessing Products Corp, from to . As of , FDA records show no recalls naming K101750.

Clearance record

Decision date
Received
(199 days to decision)
Product code
MNV Strip, Dialysate Ph Indicator
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Reprocessing Products Corp 8662 Comstock Ln. N., Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNV

Trailing 12 months

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

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