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

Strip, Dialysate Ph Indicator

REPROCESSING PRODUCTS CORP.

The following data is part of a premarket notification filed by Reprocessing Products Corp. with the FDA 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.

Pre-market Notification Details

• Device ID: K101750
• 510k Number: K101750
• Device Name: 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
• Classification: Strip, Dialysate Ph Indicator
• Applicant: REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. NORTH Maple Grove, MN 55311
• Contact: Wally Jansen
• Correspondent: Wally Jansen; REPROCESSING PRODUCTS CORP. 8662 COMSTOCK LN. NORTH Maple Grove, MN 55311
• Product Code: MNV
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-06-22
• Decision Date: 2011-01-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858293006373	K101750	000
00858293006168	K101750	000
00858293006151	K101750	000
00858293006144	K101750	000
00858293006137	K101750	000