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FDA 510(k)

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104

K-Number: K101750 · 2011-01-07

ApplicantReprocessing Products Corp
Decision Date2011-01-07
Product CodeMNV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 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 2011-01-07 under 510(k) number K101750. The device is classified under product code MNV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104?

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Reprocessing Products Corp. The 510(k) number is K101750.

When did RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 receive FDA 510(k) clearance?

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 received FDA 510(k) clearance on 2011-01-07, under 510(k) number K101750.

Who is the listed applicant for RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104?

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 RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104?

The FDA product code for RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 is MNV.

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 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 STRIPSK090338ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEK974426POTENCY TEST STRIPS, INDICATOR TEST STRIPSK974064MICRO X RESIDUAL TEST STRIPSK950602PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS

Related Devices (Code: MNV)

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 STRIPSEnvironmental Test Systems, Inc.K936311MITEK MINI ANCHORMitek Surgical Products, Inc.K941599MITEK ABSORBABLE ANCHORMitek Surgical Products, Inc.K944051ABSORBALBE ANCHORMitek Surgical Products, Inc.K945491SERIM(TM) BICARB PH REAGENT STRIPSSerim Research Corp.

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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