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

KZJ 1980-04-08

DISP. HYDROGEN & CO2 GENERATOR ENVELOPE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K800539

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CFE 1980-04-04

TRANSPHOR TM LD LACTATE DEHYDROGENASE

Applicant Corning Medical & Scientific

K-Number K800568

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GCY 1980-04-04

TLS TM SURGICAL DRAINAGE SYSTEM

Applicant Glasrock Products, Inc.

K-Number K800581

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JIS 1980-04-04

NSI CALIBRATOR SET

Applicant Nobel Scientific Industries, Inc.

K-Number K800588

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JFL 1980-04-04

NSI CARBON DIOXIDE REAGENT KIT

Applicant Nobel Scientific Industries, Inc.

K-Number K800586

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JPK 1980-04-04

HEMATO-CHEX

Applicant Streck Laboratories, Inc.

K-Number K800361

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CGR 1980-04-04

VENTRE/SEP CORTISOL RIA

Applicant Ventrex Laboratories, Inc.

K-Number K800594

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JSJ 1980-04-04

CAMPYLOBACTER AGAR W/5-ANTIMICROBICS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K800541

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GEH 1980-04-04

KRYMED LIQUID NITROGEN CRYOJET

Applicant Cryomedics, Inc.

K-Number K800335

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KHG 1980-04-04

COMPUR M-1000 MINI-PHOTOMETER

Applicant Miles Laboratories, Inc.

K-Number K800059

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N/A 1980-04-04

ANTIMICROBIAL REMOVAL DEVICE (ARD)

Applicant Marion Laboratories, Inc.

K-Number K800052

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GRO 1980-04-04

BACTOGEN-H. INFLUENZAE TYPE B

Applicant Armkel, LLC

K-Number K800493

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