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

DSH 1979-12-27

MODEL 447 ELECTROCARDIOCORDER

Applicant Del Mar Avionics

K-Number K792079

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JLW 1979-12-27

TSH RADIOIMMUNOASSAY

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K-Number K792443

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DAK 1979-12-27

ELECTRO-IMMUNO-QUANTITATION (EIQ)

Applicant Icl Scientific

K-Number K792472

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ESD 1979-12-27

RIONET HEARING AID HB-32T

Applicant Rion Acoustic Instruments, Inc.

K-Number K792505

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KGI 1979-12-27

NORLAND MODEL 278 BONE DENSITOMETER

Applicant Norland Corp.

K-Number K792444

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JER 1979-12-27

PLAQUE-X DENTURE CLEANER

Applicant Nexell Corp.

K-Number K792530

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JSH 1979-12-27

LYSINE IRON AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K792544

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CHH 1979-12-27

CHEM-STRATE CHOLESTEROL

Applicant General Diagnostics

K-Number K792478

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JJE 1979-12-27

SYSTEM 103 CHEMISTRY ANALYZER

Applicant Gilford Instrument Laboratories, Inc.

K-Number K792361

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CIJ 1979-12-27

CHEM-STRATE AMYLASE

Applicant General Diagnostics

K-Number K792479

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FLE 1979-12-27

CONTAINER SYSTEM

Applicant Aesculap Instruments Corp.

K-Number K792558

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JSE 1979-12-27

DECARBOXYLASE MOELLER BASE WITH OR WITH-

Applicant Isle Media and Sterile Products, Inc.

K-Number K792425

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