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

JLS 1980-02-13

RSL (125 L) PROGESTERONE KIT

Applicant Radioassay Systems Laboratories, Inc.

K-Number K800126

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JPK 1980-02-13

WHOLE BLOOD PLATELET CONTROL NORMAL,

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K-Number K792606

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CDO 1980-02-13

CENTRIFICHEM URIC ACID

Applicant Union Carbide Corp.

K-Number K800130

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JSI 1980-02-13

BISMUTH SULFITE AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K800157

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CEX 1980-02-13

CENTRIFICHEM CREATININE

Applicant Union Carbide Corp.

K-Number K800129

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DXK 1980-02-13

IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-

Applicant Ipco Corp.

K-Number K792373

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JQW 1980-02-13

MICROMEDIC PUNCH & ELUTER

Applicant Micromedic Systems

K-Number K800075

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CKA 1980-02-13

DURAZYME GPT/ALT

Applicant American Monitor Corp.

K-Number K800115

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CEP 1980-02-13

LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS

Applicant Radioimmunoassay, Inc.

K-Number K800106

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KHQ 1980-02-13

AMES RIALYZE - UPTAKE CHROM. TUBES

Applicant Miles Laboratories, Inc.

K-Number K800170

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CFJ 1980-02-13

LDH (L-P) REAGENT

Applicant Gilford Diagnostics

K-Number K800120

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CDH 1980-02-13

STANBIO DIRECT URIC ACID TEST SET #0770

Applicant Stanbio Laboratory

K-Number K800190

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