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

KIS 1981-09-01

ZETA-SERA D

Applicant Amf Biological and Diagnostics Co.

K-Number K812329

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IDC 1981-09-01

ACRIDINE ORANGE STAIN

Applicant Carr-Scarborough Microbiologicals, Inc.

K-Number K812212

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CZQ 1981-09-01

KAPPA & LAMBDA BENCE JONES CONTROLS

Applicant Kallestad Laboratories, Inc.

K-Number K812327

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JPK 1981-09-01

VENTREX DATA REDUCTION & QUAL. CONTR. SY

Applicant Ventrex Laboratories, Inc.

K-Number K812357

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JRE 1981-09-01

REAGENT STRIPS FOR URINALYSIS

Applicant Miles Laboratories, Inc.

K-Number K811342

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DHN 1981-09-01

CRITHIDNA ANTI-DNA TEST KIT

Applicant Antibodies, Inc.

K-Number K812314

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JHJ 1981-09-01

B-NEOCEPT

Applicant Organon, Inc.

K-Number K812334

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JFH 1981-09-01

TANDEM PAP KIT - (PARTS I & II)

Applicant Hybritech, Inc.

K-Number K811959

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FTY 1981-08-31

BORES* DEPTH GAUGE

Applicant Santa Barbara Medco, Inc.

K-Number K812069

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JKD 1981-08-31

HUMAN C-PEPTIDE REAGENTS

Applicant Immunex Radiochemical Diagnostics

K-Number K812288

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GES 1981-08-31

RK IV SURGICAL BLADES

Applicant Santa Barbara Medco, Inc.

K-Number K812071

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GMD 1981-08-31

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI

Applicant American Scientific Products

K-Number K812188

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