Medical Device Manufacturer · US , Mchenry , IL

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

20 submissions · 20 cleared · Since 1982

20

Total

20

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Jul 22, 1985

QUICK-CHEM CALIBRATION SET

Chemistry · 59d

Cleared Jun 25, 1985

CK/LD ISOENZYMES CONTROLS(HUMAN)

Chemistry · 71d

Cleared May 10, 1985

LD-1(IMMUNO) SEPARATION SET

Chemistry · 25d

Cleared Feb 27, 1985

Chemistry · 40d

Cleared Apr 13, 1984

CK/MB IMMUNO-ISOENZYME CONTROL SERUM

Chemistry · 50d

Cleared Feb 21, 1984

DIRECT IRON REAGENT SET

Chemistry · 69d

Cleared Jan 13, 1984

ALKALINE PHOSPHATASE-RATE

Chemistry · 79d

Cleared Jan 13, 1984

UREA NITROGEN-UV

Chemistry · 60d

Cleared Oct 28, 1983

ENZYMATIC GLUCOSE DETERMINATION

Chemistry · 70d

Cleared Oct 14, 1983

TOTAL IRON-BINDING CAPACITY ACCESORY

Chemistry · 56d

Cleared Oct 18, 1982

SERAGAN ACTH125 I-RIA KIT

Chemistry · 91d