Medical Device Manufacturer · US , Mchenry , IL

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

20 submissions · 20 cleared · Since 1982

Total

Cleared

Denied

Seragen Diagnostics, Inc. has 20 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 20 cleared submissions from 1982 to 1987. Primary specialty: Chemistry.

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

Seragen Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

20 devices

1-20 of 20

QUICK-COUNT HEMATOLOGY CONTROLS

K851663 · JPK

Hematology · 91d

Cleared Jul 22, 1985

QUICK-CHEM CALIBRATION SET

K852260 · JIW

Chemistry · 59d

Cleared Jun 25, 1985

CK/LD ISOENZYMES CONTROLS(HUMAN)

K851520 · JJT

Chemistry · 71d

Cleared May 10, 1985

LD-1(IMMUNO) SEPARATION SET

SERATEST ENA(RNP/SM) DETERMINATION

K844743 · LLL

Immunology · 61d

Cleared Oct 25, 1984

SERATEST DNA DETERMINATION

CK/MB IMMUNO-ISOENZYME CONTROL SERUM

K840793 · JJT

Chemistry · 50d

Cleared Apr 04, 1984

SERATEST RF LATEX DETERMINATION

K840863 · DHR

Immunology · 40d

Cleared Feb 21, 1984

DIRECT IRON REAGENT SET

K834396 · CFM

Chemistry · 69d

Cleared Feb 17, 1984

QUICK-COUNT HEMATOLOGY REAGENT KIT

ALKALINE PHOSPHATASE-RATE

ENZYMATIC GLUCOSE DETERMINATION

K832926 · CGA

Chemistry · 70d

Cleared Oct 14, 1983

TOTAL IRON-BINDING CAPACITY ACCESORY

SERAGAN ACTH125 I-RIA KIT

K822115 · CKG

Chemistry · 91d

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

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

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