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

EBF 1978-12-20

ISOPLAST

Applicant Vivadent (Usa), Inc.

K-Number K781787

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JTC 1978-12-20

WASHER SYSTEM, MICROELISA

Applicant Metrix Teknika, Inc.

K-Number K781802

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GOK 1978-12-20

RUBINDEX*DIRECT SYSTEM

Applicant Ortho Diagnostics, Inc.

K-Number K781638

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LCP 1978-12-20

COLUMN TEST, HEMOGLOBIN A

Applicant Bio-Rad

K-Number K781948

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GCY 1978-12-20

ROUND SILICONE DRAIN

Applicant Davol, Inc.

K-Number K782028

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HSZ 1978-12-20

SURGAIRTOME TWO

Applicant American Sterilizer Co.

K-Number K781979

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JJQ 1978-12-20

UROTRON

Applicant Boehringer Mannheim Corp.

K-Number K781632

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CDL 1978-12-20

UREA NITROGEN TEST

Applicant Wako Intl., Inc.

K-Number K781899

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JJY 1978-12-20

CONTROL, PROTEIN ELECTROPHORESIS

Applicant Sigma Chemical Co.

K-Number K781893

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KIE 1978-12-20

DETECTOR, MODEL 79875A, VARIABLE

Applicant Hewlett-Packard Co.

K-Number K781771

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EJK 1978-12-20

LINER, CAVITY CALCIUM HYDROXIDE

Applicant Kerr Corporation (Danbury)

K-Number K781688

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KSX 1978-12-20

BLOOD GROUP SUBSTANCE B

Applicant North American Biologicals, Inc.

K-Number K781895

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