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FDA 510(k)

POTENCY TEST STRIPS, INDICATOR TEST STRIPS

K-Number: K974426 · 1999-02-10

ApplicantReprocessing Products Corp
Decision Date1999-02-10
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

POTENCY TEST STRIPS, INDICATOR TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Reprocessing Products Corp. It received FDA 510(k) clearance on 1999-02-10 under 510(k) number K974426. 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 POTENCY TEST STRIPS, INDICATOR TEST STRIPS?

POTENCY TEST STRIPS, INDICATOR TEST STRIPS is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is Reprocessing Products Corp. The 510(k) number is K974426.

When did POTENCY TEST STRIPS, INDICATOR TEST STRIPS receive FDA 510(k) clearance?

POTENCY TEST STRIPS, INDICATOR TEST STRIPS received FDA 510(k) clearance on 1999-02-10, under 510(k) number K974426.

Who is the listed applicant for POTENCY TEST STRIPS, INDICATOR TEST STRIPS?

The FDA 510(k) record lists Reprocessing Products Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POTENCY TEST STRIPS, INDICATOR TEST STRIPS?

The FDA product code for POTENCY TEST STRIPS, INDICATOR TEST STRIPS is LIF.

Related Clinical Trials

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Other records listing Reprocessing Products Corp 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.

K123805E-Z CHEK BLOOD LEAK TEST STRIPSK101750RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104K090338ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEK974064MICRO X RESIDUAL TEST STRIPSK950602PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS

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

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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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