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FDA 510(k)

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)

K-Number: K911628 · 1991-06-27

ApplicantSerim Research Corp.
Decision Date1991-06-27
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) 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 1991-06-27 under 510(k) number K911628. 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 SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)?

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) is a medical device that received FDA 510(k) clearance on 1991-06-27. The listed applicant is Serim Research Corp.. The 510(k) number is K911628.

When did SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) receive FDA 510(k) clearance?

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) received FDA 510(k) clearance on 1991-06-27, under 510(k) number K911628.

Who is the listed applicant for SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)?

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 FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)?

The FDA product code for SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) is LIF.

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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: 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

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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