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

HYI 1978-10-10

GRAM STAIN KIT

Applicant Bioscientific

K-Number K781584

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JSJ 1978-10-10

CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH.

Applicant Anaerobe Systems

K-Number K781603

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DWS 1978-10-10

SURGITEK DISPOSABLE FLO-RESTER

Applicant Medical Engineering Corp.

K-Number K781336

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HZJ 1978-10-10

PAPANICOLAOU STAIN EA-36

Applicant Bioscientific

K-Number K781582

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ESD 1978-10-10

HEARING AID, ITE MODULAR MODEL I, II, V

Applicant Oticon Corp.

K-Number K781663

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IYN 1978-10-10

RA-I

Applicant Diasonics, Inc.

K-Number K781642

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CHJ 1978-10-10

CHLORIDE REAGENT

Applicant Analytical & Research Chemicals, Inc.

K-Number K781460

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EMX 1978-10-10

ECHO-OIL

Applicant Echo Laboratories, Inc.

K-Number K781631

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KLK 1978-10-10

TRANSCUTANEOUS OXYGEN PERFUSION MONITOR

Applicant Narco Air-Shields

K-Number K780458

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LAN 1978-10-10

EMIT N-ACETYLPROCAINAMIDE ASSAY

Applicant Syva Co.

K-Number K781378

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JSG 1978-10-10

CDC ANAEROBE BLOOD AGAR

Applicant Anaerobe Systems

K-Number K781604

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DTR 1978-10-10

HEAT EXCHANGER, FHX-14

Applicant Delta Medical Industries

K-Number K781210

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