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FDA 510(k)

GLUTARTEST 1 REAGENT STRIP

K-Number: K002011 · 2001-01-22

ApplicantIntegrated Biomedical Technology, Inc.
Decision Date2001-01-22
Product CodeMSY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GLUTARTEST 1 REAGENT STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Biomedical Technology, Inc.. It received FDA 510(k) clearance on 2001-01-22 under 510(k) number K002011. The device is classified under product code MSY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUTARTEST 1 REAGENT STRIP?

GLUTARTEST 1 REAGENT STRIP is a medical device that received FDA 510(k) clearance on 2001-01-22. The listed applicant is Integrated Biomedical Technology, Inc.. The 510(k) number is K002011.

When did GLUTARTEST 1 REAGENT STRIP receive FDA 510(k) clearance?

GLUTARTEST 1 REAGENT STRIP received FDA 510(k) clearance on 2001-01-22, under 510(k) number K002011.

Who is the listed applicant for GLUTARTEST 1 REAGENT STRIP?

The FDA 510(k) record lists Integrated Biomedical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUTARTEST 1 REAGENT STRIP?

The FDA product code for GLUTARTEST 1 REAGENT STRIP is MSY.

Related Clinical Trials

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Other records listing Integrated Biomedical Technology, 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.

K964264HIGH RANGE PEROXIDE TEST STRIPK953854WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE

Related Devices (Code: MSY)

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.

K243898Chlorine Sentinel IINelson Environmental Technologies, Inc.K222167E-Z Chek Chlorine Residual Test Strips (K100-0101B)Reprocessing Products Corporation (Rpc)K193169Nelson Sentinel Series Basic Chlorine SentinelNelson Environmental Technologies, Inc.K090338ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEReprocessing Products CorpK080712SERIM HISENSE ULTRA 0.1, PART NUMBER 5167Serim Research Corp.K001194STERICHEK TOTAL CHLORINE REAGENT STRIPSEnvironmental Test Systems, 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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