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

CHP 1980-05-14

NORDICLAB ESTRADIOL RIA TEST

Applicant Nordiclab Intl.

K-Number K800920

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N/A 1980-05-14

IMMULON 1, #11-010-3350 & IMMULON 2 #--

Applicant Dynatech Laboratories, Inc.

K-Number K801018

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IYO 1980-05-14

MODEL SKI-200 ABDOMINAL SCANNER

Applicant Smithkline Diagnostics, Inc.

K-Number K800824

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KNG 1980-05-14

FETAL HEART DETECTOR #'S D102 & D102R

Applicant Sonicaid, Inc.

K-Number K800858

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HHD 1980-05-14

PAPER-PAK OB PADS

Applicant Paper-Pak Products, Inc.

K-Number K800952

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FRN 1980-05-14

INTRAVENOUS INFUSION PUMP, CODE 2M8015

Applicant Travenol Laboratories, S.A.

K-Number K800629

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IYE 1980-05-14

TENNIS RACKET-TABLE INSERT PANEL

Applicant Radiation Products Design, Inc.

K-Number K800790

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IYE 1980-05-14

ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER

Applicant Radiation Products Design, Inc.

K-Number K800759

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JLS 1980-05-14

NORDICLAB PROGESTERONE RIA TEST

Applicant Nordiclab Intl.

K-Number K800922

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DZE 1980-05-14

PS3 TITANIUM SCREW DENTAL IMPLANT

Applicant Colmed, Ltd.

K-Number K800762

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IYE 1980-05-14

MYLAR WINDOW-TABLE INSERT PANEL

Applicant Radiation Products Design, Inc.

K-Number K800791

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DGO 1980-05-14

IMMUNOGLOBULIN E TEST KIT

Applicant Calbiochem-Behring Corp.

K-Number K800995

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