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

DEP 1980-09-16

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.

Applicant J.T. Baker Chemical Co.

K-Number K801662

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FKI 1980-09-16

HOLLOW FIBER DIALYZER HOLDER

Applicant Renal Devices, Inc.

K-Number K802075

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CEK 1980-09-16

BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM

Applicant Beckman Instruments, Inc.

K-Number K801749

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KDD 1980-09-16

SUTURE REMOVAL SET CAT.#906

Applicant Pollak (Intl.), Ltd.

K-Number K802019

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CFR 1980-09-16

GLUCOSE REAGENT(UV-HEXOKINASE)

Applicant Reagents Applications, Inc.

K-Number K801765

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CGI 1980-09-16

ARIA II 125- I-ESTRIOL SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K801735

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CIT 1980-09-16

DATA-ZYME AST(GOT) PROCEDURE

Applicant Data Medical Associates, Inc.

K-Number K801856

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KGX 1980-09-16

FIRST AID BANDAGE CAT.#198 OR 199

Applicant Pollak (Intl.), Ltd.

K-Number K802013

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GEN 1980-09-16

PLASTIC FORCEPS CAT.#1001-1010

Applicant Pollak (Intl.), Ltd.

K-Number K801991

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LBS 1980-09-16

WAKO HDL CHOLESTEROL TEST

Applicant Wako Pure Chemical Industries, Ltd.

K-Number K801834

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IQI 1980-09-16

C-SPLINT

Applicant Cutter Laboratories, Inc.

K-Number K802104

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CIX 1980-09-16

BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY

Applicant Beckman Instruments, Inc.

K-Number K801750

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