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

JJE 1982-07-13

GEMSTAR SYSTEM

Applicant Electro-Nucleonics Laboratories, Inc.

K-Number K821335

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JIX 1982-07-13

REF. ELECTRODE SOL'N.;STANDARD B

Applicant Avl Scientific Corp.

K-Number K821885

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N/A 1982-07-13

MODEL LS 3000 LINEAR SCANNER

Applicant Hitachi Medical Corp.

K-Number K827377

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LBR 1982-07-13

HDL PRECIPITANT REAGENT SET

Applicant Omega Medical Electronics

K-Number K821203

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IDS 1982-07-13

A O HISTOSTAT EMBEDDING CTR #8030,32,34

Applicant Warner-Lambert Co.

K-Number K821831

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CDT 1982-07-13

ULTRACHEM TRI-ES

Applicant Harleco Diagnostics

K-Number K821875

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CDH 1982-07-13

URIC ACID REAGENT SET

Applicant Omega Medical Electronics

K-Number K821213

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BZQ 1982-07-13

HEALTHDYNE MODEL 16900 INFANT MONITOR

Applicant Healthdyne, Inc.

K-Number K821731

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FAP 1982-07-13

UROCOMP MODEL 1404

Applicant Life-Tech Intl., Inc.

K-Number K821939

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CGE 1982-07-13

DIRECT GLUCOSE REAGENT SET

Applicant Omega Medical Electronics

K-Number K821198

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CEO 1982-07-13

ULTRACHEM PHOS

Applicant Harleco Diagnostics

K-Number K821874

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CIO 1982-07-13

ALKALINE PHOSPHOTASE REAGENT SET

Applicant Omega Medical Electronics

K-Number K821200

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