Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

K-Number: K974798 · 1998-03-20

ApplicantEnvironmental Test Systems, Inc.
Decision Date1998-03-20
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Test Systems, Inc.. It received FDA 510(k) clearance on 1998-03-20 under 510(k) number K974798. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS?

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS is a medical device that received FDA 510(k) clearance on 1998-03-20. The listed applicant is Environmental Test Systems, Inc.. The 510(k) number is K974798.

When did STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS receive FDA 510(k) clearance?

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS received FDA 510(k) clearance on 1998-03-20, under 510(k) number K974798.

Who is the listed applicant for STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS?

The FDA 510(k) record lists Environmental Test Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS?

The FDA product code for STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS is LIF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Environmental Test Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031267STERICHEK BICARB PH REAGENT STRIPSK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSK001194STERICHEK TOTAL CHLORINE REAGENT STRIPSK994226STERICHEK TOTAL CHLORINE REAGENT STRIPSK983997STERICHEK TOTAL CHLORINE TEST KITK980164STERICHEK PERACETIC ACID REAGENT STRIPS

View all 8 devices →

Related Devices (Code: LIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑