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

GMN 1979-09-24

AGGLUTINOTEST-TOXOPLASMOSIS

Applicant Volu Sol Medical Industries

K-Number K791456

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CDT 1979-09-24

COULTER ACCU-ZYME II ENZYMATIC REAGENT

Applicant Coulter Electronics, Inc.

K-Number K791640

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N/A 1979-09-24

THE GALASSIA SYSTEM

Applicant Ariel

K-Number K791191

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JSG 1979-09-24

TRYPTIC SOY AGAR 5% SHEEP BLOOD

Applicant American Laboratory Supply, Inc.

K-Number K791620

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JTZ 1979-09-24

MUELLER-HINTON AGAR

Applicant American Laboratory Supply, Inc.

K-Number K791624

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DHN 1979-09-24

ANTI-NUCLEAR ANTIBODY TEST

Applicant Meloy Laboratories, Inc.

K-Number K791493

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FJI 1979-09-24

ERIKA HPF 100

Applicant Erika, Inc.

K-Number K791320

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FJI 1979-09-24

ERIKA HPF 300

Applicant Erika, Inc.

K-Number K791322

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GNC 1979-09-24

AGGLUTINOTEST-SALMONELLA

Applicant Volu Sol Medical Industries

K-Number K791450

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DCK 1979-09-24

GOAT ANTI-HUMAN C-REACTIVE PROTEIN

Applicant Protos Laboratories

K-Number K791560

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GPF 1979-09-24

AGGLUTINOTEST-ECHINOCOCCOSIS

Applicant Volu Sol Medical Industries

K-Number K791451

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GTN 1979-09-24

AGGLUTINOTEST-STAPHYLOLISIN

Applicant Volu Sol Medical Industries

K-Number K791453

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