Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LAR 1979-03-21

EMIT QUINIDINE ASSAY

Applicant Syva Co.

K-Number K790403

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KTQ 1979-03-21

LOW-TOX-H RABBIT COMPLEMENT

Applicant Cederlane Labs , Ltd.

K-Number K790380

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CFE 1979-03-21

LDH ISOENZYME REAGENT

Applicant Electrophoresis Corp.

K-Number K790311

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LBS 1979-03-21

DIAGNOSTIC SET, LIPO-FRAX

Applicant Analytical Products, Inc.

K-Number K790281

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JJX 1979-03-21

SERUM PAK, HCG CONTROL

Applicant Mallinckrodt Critical Care

K-Number K790129

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JHX 1979-03-21

BUFFER, CORNING MOPSO

Applicant Corning Medical & Scientific

K-Number K790294

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KXO 1979-03-21

MODEL 8100 PRE-FILLED INTRAUTERINE

Applicant Ge Medical Systems Information Technologies

K-Number K790418

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GXY 1979-03-21

STIMTECH TENS ELECTRODE

Applicant Stimulation Technology, Inc.

K-Number K790345

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CGE 1979-03-21

ORTHO-TOLUIDINE REAGENT SET

Applicant Fisher Scientific Co., LLC

K-Number K790319

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IYO 1979-03-21

ULTRASONIC DIAGNOSTIC SYSTEM

Applicant Hoffrel Instruments, Inc.

K-Number K790396

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CEW 1979-03-21

RIA SYSTEM, PARATHYROID HORMONE

Applicant Iso-Tex Diagnostics

K-Number K782081

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EBF 1979-03-21

PHASEAFILL

Applicant Phasealloy

K-Number K782165

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