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

CHO 1981-07-10

KING DIAGNOSTICS CHOLESTEROL-FE TEST

Applicant King Diagnostics, Inc.

K-Number K811746

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CEF 1981-07-10

TBG DIAGNOSTIC KIT

Applicant Immuno Assay Corp.

K-Number K811725

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CDX 1981-07-10

QUANTAPHASE T-4 RIA

Applicant Bio-Rad

K-Number K811787

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FRN 1981-07-10

ENTRI ENTERAL FEEDING PUMP

Applicant Biosearch Medical Products, Inc.

K-Number K811739

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DBF 1981-07-10

FERRITIN RIA KIT

Applicant Amersham Corp.

K-Number K811804

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DSF 1981-07-10

PAPER CHART RECORDER

Applicant American Edwards Laboratories

K-Number K811254

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DLP 1981-07-10

KALLESTAD ANTISERA TO PHENYTOIN

Applicant Kallestad Laboratories, Inc.

K-Number K811775

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KNT 1981-07-10

MGN FEEDING TUBE

Applicant Mgn Medical Manufacturing, Inc.

K-Number K811533

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CGO 1981-07-10

KING DIAGNOSTICS CHOLESTEROL TEST

Applicant King Diagnostics, Inc.

K-Number K811747

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DPO 1981-07-10

KALLESTAD QUANTICOAT 125 DIGOXIN

Applicant Kallestad Laboratories, Inc.

K-Number K811776

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IYO 1981-07-10

CIRAS ULTRASONIC SCANNING SYSTEM

Applicant Ausonics Pty , Ltd.

K-Number K811633

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LER 1981-07-10

FLUOROMATIC THEOPHYLLINE FIA

Applicant Bio-Rad

K-Number K811856

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