Medical Device Manufacturer · US , Mchenry , IL

Seratronics, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1982

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Seratronics, Inc. Gastroenterology & Urology ✕

20 devices

1-12 of 20

Cleared Oct 21, 1996

DPS 4 DIALYZER PREPARATION SYSTEM

Gastroenterology & Urology · 336d

Cleared Apr 18, 1996

DRS 4 DIALYZER REPROCESSING SYSTEM

Gastroenterology & Urology · 1129d

Cleared Nov 29, 1995

DRS 4 ND DIALYZER REPROCESSING SYSTEM

Gastroenterology & Urology · 440d

Cleared Aug 29, 1994

DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES

Gastroenterology & Urology · 774d

Cleared Feb 24, 1992

DRS-4 DIALYZER REPROCESSING SYSTEM

Gastroenterology & Urology · 131d

Cleared Apr 25, 1988

FRESENIUS PURISTERIL 340 (TM)

Gastroenterology & Urology · 172d

Cleared Feb 19, 1988

FRESENIUS HEMOFLOW F3, F4, F5, F7

Gastroenterology & Urology · 84d

Cleared May 01, 1987

FRESENIUS HEMOFLOW F6 AND F8

Gastroenterology & Urology · 66d

Cleared Apr 01, 1987

FRESENIUS HEMOFLOW F60 AND F80

Gastroenterology & Urology · 36d

Cleared Mar 03, 1987

FRESENIUS ULTRAFLUX AV400, AV600

Gastroenterology & Urology · 102d

Cleared Nov 06, 1986

FRESENIUS HEMOFLOW F50 & F70

Gastroenterology & Urology · 13d

Cleared Apr 07, 1986

DRS-4 DIALYZER REPROCESSING SYSTEM

Gastroenterology & Urology · 42d