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FDA 510(k)

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS

K-Number: K003615 · 2001-02-01

ApplicantEnvironmental Test Systems, Inc.
Decision Date2001-02-01
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS 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 2001-02-01 under 510(k) number K003615. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS?

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is Environmental Test Systems, Inc.. The 510(k) number is K003615.

When did STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS receive FDA 510(k) clearance?

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS received FDA 510(k) clearance on 2001-02-01, under 510(k) number K003615.

Who is the listed applicant for STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS?

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 SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS?

The FDA product code for STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS is FKP.

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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 STRIPSK001194STERICHEK TOTAL CHLORINE REAGENT STRIPSK994226STERICHEK TOTAL CHLORINE REAGENT STRIPSK983997STERICHEK TOTAL CHLORINE TEST KITK980164STERICHEK PERACETIC ACID REAGENT STRIPSK974798STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

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Related Devices (Code: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK992255CKHEMO, MODEL CKHEMO VERSION 1.0Csam, Inc.

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.

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