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

DTR 1980-04-16

TOPICAL COOLING DEV. TCD. #27-999

Applicant Cobe Laboratories, Inc.

K-Number K800717

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N/A 1980-04-16

SMAC REPLACEMENT REAGENTS, WETTING AGENT

Applicant Diagnostic Solutions, Inc.

K-Number K800670

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ETF 1980-04-16

DUNRICH TABLES

Applicant Dunrich, Inc.

K-Number K800756

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GCY 1980-04-16

SNYDER HYSTERECTOMY Y TUBE KIT

Applicant Snyder Laboratories, Inc.

K-Number K800543

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JQP 1980-04-16

AMES LAB MANAGEMENT SYSTEM

Applicant Miles Laboratories, Inc.

K-Number K800724

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JJX 1980-04-16

CODE QAS.105 PROLACTIN CONTROL SERA

Applicant Amersham Corp.

K-Number K800708

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DBF 1980-04-16

FERRITIN CONTROLS CODE QAS.104

Applicant Amersham Corp.

K-Number K800657

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DXY 1980-04-16

NOMOS-01 PULSE GENERATOR

Applicant Biotronik Sales, Inc.

K-Number K800375

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CFT 1980-04-16

PROLACTIN RIA KIT

Applicant Amersham Corp.

K-Number K800740

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DQO 1980-04-16

CENTRAL VEIN CATHETERIZATION KIT

Applicant Medical Components, Inc.

K-Number K800741

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KSF 1980-04-16

RST-SERIES CONTROL

Applicant Gamma Biologicals, Inc.

K-Number K800658

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GKL 1980-04-16

HEMOSAFE

Applicant Med Lab Systems, Inc.

K-Number K800346

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