Medical Device Manufacturer · US , Elkhart , IN

Serim Research Corp. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1990

Recent clearances: RAPICIDE OPA-28 TEST STRIP, SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171, SERIM DISINTEK GTA 2.1%, MODEL: 5164

Official Website

27

Total

27

Cleared

0

Denied

FDA 510(k) Regulatory Record - Serim Research Corp. Gastroenterology & Urology ✕

12 devices

1-12 of 12

Cleared May 06, 2008

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

Gastroenterology & Urology · 54d

Cleared Jun 13, 2005

SERIM DIALYSATE MONITOR TEST STRIP

Gastroenterology & Urology · 222d

Cleared Nov 30, 2001

SERIM BLOOD LEAK TEST STRIP-2

Gastroenterology & Urology · 147d

Cleared Apr 21, 1999

SERIM BLOOD LEAK TEST STRIP

Gastroenterology & Urology · 90d

Cleared Aug 09, 1995

SERIM HISENSE TEST KIT

Gastroenterology & Urology · 90d

Cleared Feb 01, 1995

SERIM(TM) BICARB PH REAGENT STRIPS

Gastroenterology & Urology · 85d

Cleared Apr 09, 1992

SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS

Gastroenterology & Urology · 209d

Cleared Jun 27, 1991

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)

Gastroenterology & Urology · 77d

Cleared Jun 27, 1991

SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)

Gastroenterology & Urology · 77d

Cleared Apr 02, 1991

SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT

Gastroenterology & Urology · 320d

Cleared Sep 13, 1990

SERIM RESIDUAL CHLORINE TEST KIT

Gastroenterology & Urology · 149d

Cleared Jul 11, 1990

SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT

Gastroenterology & Urology · 170d