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

DFC 1977-10-19

LAS-R BETA LIPOPROTEIN TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K-Number K771912

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JSI 1977-10-19

JEMBEC-CVSB PLATE

Applicant J.P. Kilbourn, Ph.D.

K-Number K771647

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JJT 1977-10-19

CARDIOZYME CK-CONTROL LEVEL 1

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K-Number K771740

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JAK 1977-10-19

EMI CTR 100

Applicant Emi Medical, Inc.

K-Number K771811

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CHH 1977-10-19

ENZYMATIC CHOLESTEROL

Applicant Macomb Chemical Co.

K-Number K771820

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HEM 1977-10-19

ROCHE AXISCAN 5

Applicant Roche Medical Electronics, Inc.

K-Number K771816

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IYE 1977-10-19

CLINAC 6/100

Applicant Varian Assoc., Inc.

K-Number K771809

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CGX 1977-10-19

PROCEDURE NO. 555

Applicant Sigma Chemical Co.

K-Number K771916

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CHL 1977-10-19

BG II ANALYZER

Applicant Technicon Instruments Corp.

K-Number K771822

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IYE 1977-10-19

EMI FOUR

Applicant Emi Therapy Systems, Inc.

K-Number K771902

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CIG 1977-10-19

TOTAL BILIRUBIN

Applicant Gamma Enterprises, Inc.

K-Number K771840

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IYE 1977-10-19

CLINAC 4/100

Applicant Varian Assoc., Inc.

K-Number K771808

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