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

GTZ 1980-10-10

SERO STREP KIT

Applicant Sacks Farms Biological Products

K-Number K801775

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FSM 1980-10-10

CUSTOM UNIVERSAL CUTDOWN PREP TRAY

Applicant American Pharmaseal Div. Ahsc

K-Number K801965

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FMH 1980-10-10

SPECIMEN SET

Applicant American Pharmaseal Div. Ahsc

K-Number K802340

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EJK 1980-10-10

S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX

Applicant Pennwalt Corp.

K-Number K801860

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KNK 1980-10-10

URIC ACID DIAGNOSTIC REAGENT

Applicant Connecticut Diagnostics, Ltd.

K-Number K801898

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JGJ 1980-10-10

AMERICAN MONITOR MAGNESIUM #'S 1036&4021

Applicant American Monitor Corp.

K-Number K802091

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FMP 1980-10-10

ARTERIAL BLOOD SAMPLING KIT

Applicant Current Technologies, Inc.

K-Number K802185

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CEM 1980-10-10

POSTASSIUM BUFFER SOL. & WASH SOLUTION

Applicant Panmed, Inc.

K-Number K802158

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JJY 1980-10-10

KEMTROL SERUM CONTROL ABNORMAL

Applicant Helena Laboratories

K-Number K802109

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ESD 1980-10-10

E1 SERIES HEARING AID

Applicant Western Advanced Technology, Inc.

K-Number K802324

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JFS 1980-10-10

BAKER DIAG. ULTRARATE CHLORIDE KIT

Applicant J.T. Baker Chemical Co.

K-Number K802080

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CDW 1980-10-10

BUN COLOR REAGENT & BUN ACID USED

Applicant Panmed, Inc.

K-Number K802160

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