Medical Device Manufacturer · US , San Diego , CA

ACON Laboratories, Inc. - FDA 510(k) Cleared Devices

85 submissions · 85 cleared · Since 1998
85
Total
85
Cleared
0
Denied
85 devices
51-75 of 85
Cleared Aug 30, 2004
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685 · DKZ
Toxicology · 69d
Cleared Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · JHI
Chemistry · 28d
Cleared Jun 17, 2004
FSH MENOPAUSE PREDICTOR TEST
K041165 · CGJ
Chemistry · 44d
Cleared May 19, 2004
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST...
K040445 · JXN
Toxicology · 89d
Cleared May 03, 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · DJG
Toxicology · 88d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST...
K032903 · DIO
Toxicology · 153d
Cleared Feb 17, 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST...
K033047 · DJG
Toxicology · 141d
Cleared Dec 12, 2003
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · LAF
Toxicology · 59d
Cleared Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
K033041 · LCX
Chemistry · 53d
Cleared Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661 · LCX
Chemistry · 47d
Cleared Sep 22, 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510 · LCX
Chemistry · 39d
Cleared Aug 04, 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM...
K031759 · DKZ
Toxicology · 59d
Cleared Jul 14, 2003
ACON STREP A RAPID TEST DEVICE
K031784 · GTY
Microbiology · 34d
Cleared Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · LYR
Microbiology · 93d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP...
K023946 · DIS
Toxicology · 70d
Cleared Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · LAF
Chemistry · 84d
Cleared Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526 · LFG
Chemistry · 68d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · DIO
Toxicology · 68d
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · DJG
Toxicology · 67d
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES...
K012824 · DIS
Toxicology · 78d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · DJR
Toxicology · 66d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · JXM
Toxicology · 59d
Cleared Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · CEP
Chemistry · 37d
Cleared Aug 09, 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE...
K011730 · LCM
Toxicology · 65d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · LCX
Chemistry · 22d

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