Serim Research Corp. - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Serim Research Corp. Gastroenterology & Urology ✕
12 devices
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