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FDA 510(k)

HIGH RANGE PEROXIDE TEST STRIP

K-Number: K964264 · 1997-06-16

ApplicantIntegrated Biomedical Technology, Inc.
Decision Date1997-06-16
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HIGH RANGE PEROXIDE TEST 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 1997-06-16 under 510(k) number K964264. 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 HIGH RANGE PEROXIDE TEST STRIP?

HIGH RANGE PEROXIDE TEST STRIP is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Integrated Biomedical Technology, Inc.. The 510(k) number is K964264.

When did HIGH RANGE PEROXIDE TEST STRIP receive FDA 510(k) clearance?

HIGH RANGE PEROXIDE TEST STRIP received FDA 510(k) clearance on 1997-06-16, under 510(k) number K964264.

Who is the listed applicant for HIGH RANGE PEROXIDE TEST 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 HIGH RANGE PEROXIDE TEST STRIP?

The FDA product code for HIGH RANGE PEROXIDE TEST STRIP is FKP.

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.

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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.

K002011GLUTARTEST 1 REAGENT STRIPK953854WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE

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 AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

Official Source

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

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