JIL · Class II · 21 CFR 862.1340

FDA Product Code JIL: Method, Enzymatic, Glucose (urinary, Non-quantitative)

Leading manufacturers include Syn-Kit, Inc., Teco Diagnostics and DFI Co., Ltd..

81
Total
81
Cleared
152d
Avg days
1977
Since
81 devices
25–48 of 81
Cleared Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
K022386
Arkray, Inc.
Chemistry · 57d
Cleared Mar 21, 2002
URS-IG (GLUCOSE TEST)
K020175
Teco Diagnostics
Chemistry · 63d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 17, 1999
MEDI-TEST COMBI 11
K991927
Macherey-Nagel-Duren
Chemistry · 101d
Cleared Oct 20, 1997
DBEST REAGENT STRIP FOR URINALYSIS
K973142
Ameritek, Inc.
Chemistry · 60d
Cleared Apr 08, 1997
CLINISTRIP
K970250
Teco Diagnostics
Chemistry · 76d
Cleared Jul 26, 1996
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K954968
Tcpi, Inc.
Chemistry · 273d
Cleared Jun 18, 1996
DIA SCREEN 10 WAY REAGENT STRIPS
K961375
Genesis Labs, Inc.
Chemistry · 70d
Cleared Jun 14, 1996
FIRST CHOICE GLUCOSE URINE TEST STRIPS
K953661
Polymer Technology Intl.
Chemistry · 312d
Cleared Mar 24, 1995
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648
Teco Diagnostics
Chemistry · 294d
Cleared Sep 09, 1994
URINE REAGENT STRIP-3 PARAMETERS
K940469
Teco Diagnostics
Chemistry · 219d
Cleared Jan 11, 1990
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Mar 06, 1987
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500
American Diagnostic Corp.
Chemistry · 30d
Cleared Oct 03, 1986
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255
Behring Diagnostics, Inc.
Chemistry · 183d
Cleared Jun 13, 1986
BIOTEL (TM)/ DIABETES
K855239
American Diagnostic Corp.
Chemistry · 164d
Cleared Dec 18, 1984
UROPAPER EIKEN GP
K843753
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 7
K843754
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 6B
K843755
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 5
K843756
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN AG
K843757
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN GK
K843758
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN HAG
K843759
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN G
K843760
Syn-Kit, Inc.
Chemistry · 84d