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FDA 510(k)

SERIM(TM) BICARB PH REAGENT STRIPS

K-Number: K945491 · 1995-02-01

ApplicantSerim Research Corp.
Decision Date1995-02-01
Product CodeMNV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIM(TM) BICARB PH REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corp.. It received FDA 510(k) clearance on 1995-02-01 under 510(k) number K945491. 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 SERIM(TM) BICARB PH REAGENT STRIPS?

SERIM(TM) BICARB PH REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Serim Research Corp.. The 510(k) number is K945491.

When did SERIM(TM) BICARB PH REAGENT STRIPS receive FDA 510(k) clearance?

SERIM(TM) BICARB PH REAGENT STRIPS received FDA 510(k) clearance on 1995-02-01, under 510(k) number K945491.

Who is the listed applicant for SERIM(TM) BICARB PH REAGENT STRIPS?

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

What is the FDA product code for SERIM(TM) BICARB PH REAGENT STRIPS?

The FDA product code for SERIM(TM) BICARB PH REAGENT STRIPS is MNV.

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Other records listing Serim Research 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.

K120652RAPICIDE OPA-28 TEST STRIPK092346SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171K083295SERIM DISINTEK GTA 2.1%, MODEL: 5164K082352SERIM DISINTEK OPA TEST STRIPK081370SERIM DISINTEK OPA TEST STRIPK080712SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

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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.

K101750RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104Reprocessing Products CorpK031267STERICHEK BICARB PH REAGENT STRIPSEnvironmental Test Systems, Inc.K936311MITEK MINI ANCHORMitek Surgical Products, Inc.K941599MITEK ABSORBABLE ANCHORMitek Surgical Products, Inc.K944051ABSORBALBE ANCHORMitek Surgical Products, 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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