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

LCM 1979-06-15

PHENCYCLIDINE URINE ASSAY

Applicant Syva Co.

K-Number K790401

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DLJ 1979-06-15

URINE MEDIUM CALIBRATOR

Applicant Syva Co.

K-Number K790399

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CDX 1979-06-15

CENTRIA T4 RIA TEST SET

Applicant Ventrex Laboratories, Inc.

K-Number K790800

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JJM 1979-06-15

OSMOMETER MODEL 3W11

Applicant Advanced Instruments, Inc.

K-Number K790611

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JHJ 1979-06-15

PREGNOSTICON PREGNANCY TEST KIT

Applicant Organon, Inc.

K-Number K790734

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CGZ 1979-06-15

NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER

Applicant Nova Corp.

K-Number K790653

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JTC 1979-06-15

HISTO-OILER

Applicant Dynatech Laboratories, Inc.

K-Number K790956

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HRW 1979-06-15

MUSCLE TESTING GUN

Applicant The Orthodyn Co.

K-Number K791021

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KXT 1979-06-15

EMIT AUTO DIGOXIN ASSAY

Applicant Syva Co.

K-Number K790937

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DLJ 1979-06-15

EMIT-D.A.U. PHENCYCLIDINE URINE LOW

Applicant Syva Co.

K-Number K790398

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DJB 1979-06-15

AMES TDA/GENTGMICIN

Applicant Miles Laboratories, Inc.

K-Number K790584

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EHK 1979-06-15

PROPHYLAXIS CUPS AND POLISHERS

Applicant Young Dental Manufacturing Co. 1, LLC

K-Number K790723

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