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

JTO 1981-12-17

MS-2 BACTERIAL IDENTIFICATION SYS

Applicant Abbott Laboratories

K-Number K813031

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CGJ 1981-12-17

ANDRIA-FSH RIA TEST KIT

Applicant Intl. Immunoassay Laboratories, Inc.

K-Number K813086

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JFH 1981-12-17

RIAGEN PAP RIA

Applicant Biogenex Laboratories

K-Number K813261

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JHG 1981-12-17

SECURE FDI TEST KIT

Applicant Beckman Instruments, Inc.

K-Number K813216

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JJY 1981-12-17

ORTHO* UNASSAYED CONTROL SERUM LEVEL I

Applicant Ortho Diagnostic Systems, Inc.

K-Number K813321

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DHR 1981-12-17

RA-80 POSITIVE CONTROL

Applicant Sun-Kit

K-Number K813309

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CGA 1981-12-17

ASTRA REAGENT CONCENTRATE SYSTEM

Applicant Nobel Scientific Industries, Inc.

K-Number K812866

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JJY 1981-12-17

ORTHO CO2 DILUENT LEVEL I

Applicant Ortho Diagnostic Systems, Inc.

K-Number K813293

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LCX 1981-12-17

A-1 IN-HOME PREGNANCY TEST

Applicant C.F. Medical, Inc.

K-Number K813272

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DDG 1981-12-17

NEIA TRANSFERRIN ENZYMEIMMUNOASSAY

Applicant New England Immunology Assoc.

K-Number K813288

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JHX 1981-12-17

ABURIA-CK RIA TEST KIT

Applicant Intl. Immunoassay Laboratories, Inc.

K-Number K813087

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JHJ 1981-12-17

ACU-SLIDE TEST

Applicant C.F. Medical, Inc.

K-Number K812789

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