Cleared Traditional

K983997 - STERICHEK TOTAL CHLORINE TEST KIT

K983997 is an FDA 510(k) clearance for STERICHEK TOTAL CHLORINE TEST KIT, manufactured by Environmental Test Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSY cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K983997 · Environmental Test Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
143d
Days
Class 2
Risk

K983997 is an FDA 510(k) clearance for the STERICHEK TOTAL CHLORINE TEST KIT. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Environmental Test Systems, Inc. devices

FDA 510(k) Submission Details - K983997

510(k) Number K983997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1998
Decision Date April 02, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 131d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSY Device Classification - Class 2, Special Controls

Product Code MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

All 11
Devices cleared under the same product code (MSY) and FDA review panel - the closest regulatory comparables to K983997.
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
K080712 · Serim Research Corp. · May 2008
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K001194 · Environmental Test Systems, Inc. · Jul 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K994226 · Environmental Test Systems, Inc. · Mar 2000
MICRO X RESIDUAL TEST STRIPS
K974064 · Reprocessing Products Corp · Dec 1998
STERICHEK PERACETIC ACID REAGENT STRIPS
K980164 · Environmental Test Systems, Inc. · Apr 1998
STERICHEK CHLORINE REAGENT STRIPS
K971598 · Environmental Test Systems, Inc. · Jul 1997