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FDA 510(k)

SERIM BLOOD LEAK TEST STRIP

K-Number: K990206 · 1999-04-21

ApplicantSerim Research Corp.
Decision Date1999-04-21
Product CodeFJD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIM BLOOD LEAK TEST STRIP 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 1999-04-21 under 510(k) number K990206. The device is classified under product code FJD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIM BLOOD LEAK TEST STRIP?

SERIM BLOOD LEAK TEST STRIP is a medical device that received FDA 510(k) clearance on 1999-04-21. The listed applicant is Serim Research Corp.. The 510(k) number is K990206.

When did SERIM BLOOD LEAK TEST STRIP receive FDA 510(k) clearance?

SERIM BLOOD LEAK TEST STRIP received FDA 510(k) clearance on 1999-04-21, under 510(k) number K990206.

Who is the listed applicant for SERIM BLOOD LEAK TEST STRIP?

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 BLOOD LEAK TEST STRIP?

The FDA product code for SERIM BLOOD LEAK TEST STRIP is FJD.

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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: FJD)

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 STRIPSReprocessing Products CorpK042322STERICHEK BLOOD LEAK REAGENT STRIPSHach CompanyK012115SERIM BLOOD LEAK TEST STRIP-2Serim 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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