Medical Device Manufacturer · US , Mchenry , IL

Smithkline Diagnostics, Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1976

Total

Cleared

Denied

Smithkline Diagnostics, Inc. has 42 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 42 cleared submissions from 1976 to 1996. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Smithkline Diagnostics, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Smithkline Diagnostics, Inc.

42 devices

1-12 of 42

FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT...

HEMOCCULT SENSITIVE TEST

K880499 · KHE

Hematology · 108d

Cleared Mar 01, 1988

(SKD) CHOLESTEROL TEST KIT

SKD ELECTROCHEMICAL SYSTEM (ECS)

K854723 · CEM

Chemistry · 103d

Cleared Jul 24, 1985

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST

SPINCHEM ACID PHOSPHATASE REAGENT

K821674 · CKB

Hematology · 15d

Cleared May 24, 1982

SPIN CHEM REAGENTS & STANDARDS

K821184 · JIY

Chemistry · 27d

Cleared May 14, 1982

TARGET ISOCHECK CONTROL SERUM

K821183 · JJT

Chemistry · 17d

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Smithkline Diagnostics, Inc. - FDA 510(k) Cleared Devices

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