ACON Laboratories, Inc. - FDA 510(k) Cleared Devices
85
Total
85
Cleared
0
Denied
45 devices
Cleared
Oct 12, 2007
ACON UTI URINARY TRACT INFECTION TEST STRIPS
Chemistry
345d
Cleared
Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
Chemistry
118d
Cleared
Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
Chemistry
63d
Cleared
May 20, 2005
ACON +/- MIDSTREAM PREGNANCY TEST
Chemistry
79d
Cleared
Sep 16, 2004
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
Chemistry
72d
Cleared
Sep 09, 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
Chemistry
31d
Cleared
Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
Chemistry
28d
Cleared
Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
Chemistry
44d
Cleared
Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
Chemistry
53d
Cleared
Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
Chemistry
47d
Cleared
Sep 22, 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
Chemistry
39d
Cleared
Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
Chemistry
84d
Cleared
Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
Chemistry
68d
Cleared
Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
Chemistry
37d
Cleared
Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
Chemistry
22d
Cleared
Jan 20, 2000
ACON ONE STEP HOME PREGNANCY TEST STRIP
Chemistry
98d
Cleared
Dec 01, 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
Chemistry
68d
Cleared
Dec 01, 1999
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
Chemistry
58d
Cleared
Oct 08, 1999
ACON COMBO PREGNANCY
Chemistry
25d
Cleared
Nov 18, 1998
ACON MIDSTREAM PREGNANCY TEST
Chemistry
76d