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

IXA 1981-10-19

PLASTILIX MINIRAD D CASSETTE

Applicant Eastman Kodak Company

K-Number K812535

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DBF 1981-10-19

FERRITIN KIT

Applicant Hybritech, Inc.

K-Number K812597

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JIY 1981-10-19

DIRECT IRON REAGENT SET

Applicant The Dow Chemical Co.

K-Number K812777

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IYO 1981-10-19

SCANNER 700

Applicant National Ultrasound Corp.

K-Number K812588

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KDJ 1981-10-19

PERITONEAL DIALYSIS CYCLER SET (8UNIT)

Applicant Dravon Medical, Inc.

K-Number K812772

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JJY 1981-10-19

BECKMAN ICS NORMAL CONTROL SERA

Applicant Beckman Instruments, Inc.

K-Number K812650

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LCS 1981-10-19

ULTRA-DIG

Applicant Antibodies, Inc.

K-Number K812749

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EQN 1981-10-19

MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P

Applicant Machida America, Inc.

K-Number K812734

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JSI 1981-10-19

SEPTI-CHECK BLOOD CULTURE SLIDE

Applicant Hoffmann-La Roche, Inc.

K-Number K812731

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CIG 1981-10-19

BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN

Applicant Beckman Instruments, Inc.

K-Number K812754

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JSG 1981-10-19

SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE

Applicant Hoffmann-La Roche, Inc.

K-Number K812732

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JSG 1981-10-19

SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE

Applicant Hoffmann-La Roche, Inc.

K-Number K812729

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