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

CFJ 1983-07-19

ASTRA SYSTEMS ENZYME MODULE LD-P

Applicant Beckman Instruments, Inc.

K-Number K832048

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DFS 1983-07-19

RABBIT ANTISERUM TO HUMAN IGM

Applicant Dako Corp.

K-Number K831907

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JHI 1983-07-19

HCG ACCU-STICK

Applicant Btc Diagnostics, Inc.

K-Number K831604

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CGA 1983-07-19

GLUCOSE REAGENT B6360-11

Applicant American Scientific Products

K-Number K831634

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BTT 1983-07-19

VAPOR-PHASE HUMIDIFIER SYSTEM

Applicant Cygnus Research Corp.

K-Number K831556

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CIB 1983-07-19

RENAK

Applicant Hoffmann-La Roche, Inc.

K-Number K831694

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DEO 1983-07-19

RABBIT ANTISERUM TO HUMAN KAPPA LIGHT

Applicant Dako Corp.

K-Number K831904

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DXN 1983-07-19

GP-303

Applicant Hirata Sangyo Co. USA, Inc.

K-Number K831583

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DXH 1983-07-19

PECGASYS REMOTE TRANSMISSION UNIT

Applicant Datamedix

K-Number K831092

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FIR 1983-07-19

INFUSION PUMP

Applicant Cryosan, Inc.

K-Number K831953

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DSY 1983-07-19

VASCULAR GRAFT PROSTHESIS EXPANDED MICR

Applicant Impra, Inc.

K-Number K830543

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LAS 1983-07-19

EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO

Applicant Syva Co.

K-Number K831979

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