STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

Dialyzer Reprocessing System

ENVIRONMENTAL TEST SYSTEMS, INC.

The following data is part of a premarket notification filed by Environmental Test Systems, Inc. with the FDA for Sterichek(tm) Residual Peroxide Reagent Strps.

Pre-market Notification Details

• Device ID: K974798
• 510k Number: K974798
• Device Name: STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
• Classification: Dialyzer Reprocessing System
• Applicant: ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 P.O.BOX 4659 Elkhart, IN 46514
• Contact: Bruce G Piekarski
• Correspondent: Bruce G Piekarski; ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 P.O.BOX 4659 Elkhart, IN 46514
• Product Code: LIF
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-22
• Decision Date: 1998-03-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851575007075	K974798	000
00851575007044	K974798	000
00851575007389	K974798	000
00898021000235	K974798	000