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

JJC 1980-08-20

BMC RIAFLO SYSTEM

Applicant Boehringer Mannheim Corp.

K-Number K801481

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KNK 1980-08-20

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES

Applicant Eastman Kodak Company

K-Number K801649

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LES 1980-08-20

AMES TDA TM PHENYTOIN TEST

Applicant Miles Laboratories, Inc.

K-Number K801736

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KKX 1980-08-20

BARRIER TOWEL DRAPE

Applicant Surgikos, Inc.

K-Number K801863

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JTO 1980-08-20

ENZYME-ASE I TUBES

Applicant Microchemical Specialities, Co.

K-Number K801915

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JQP 1980-08-20

SERALYZER GLUCOSE TEST MODULE

Applicant Miles Laboratories, Inc.

K-Number K801664

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DYG 1980-08-20

CORDIS FLOW DIRECTED BALLOON CATHETER

Applicant Cordis Corp.

K-Number K801865

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LCH 1980-08-20

CORNING 184 BLOOD GAS TONOMETER

Applicant Corning Medical & Scientific

K-Number K801599

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DBF 1980-08-20

FERRIZYME FERRITIN ENZYME IMMUNOASSAY

Applicant Abbott Laboratories

K-Number K801676

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IWE 1980-08-20

WALL MOUNTED LASER POSITIONING DEVICE

Applicant Advantage Medical Systems, Inc.

K-Number K801541

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FZT 1980-08-20

SUTURE REMOVAL PAK

Applicant Devco Medical Industries, Inc.

K-Number K801746

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GOL 1980-08-20

ANTIGEN CONTROL CELLS

Applicant Ortho Diagnostics, Inc.

K-Number K801507

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