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
26-50 of 85
Cleared Apr 18, 2012
ON CALL CHOSEN LANCING DEVICE
K113332 · FMK
General & Plastic Surgery · 156d
Cleared Apr 09, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
K112653 · JJX
Chemistry · 210d
Cleared Mar 06, 2012
FORESIGHT U120 URINE ANALYZER
K120124 · JIL
Chemistry · 49d
Cleared Jan 18, 2012
MISSION U500 URINE ANALYZER
K111221 · JIO
Chemistry · 261d
Cleared Oct 06, 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · CGA
Chemistry · 143d
Cleared Feb 02, 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION...
K103387 · JJW
Chemistry · 76d
Cleared Jan 07, 2011
ON CALL PLUS DIABETES MONITORING SOFTWARE
K101371 · NBW
Chemistry · 235d
Cleared Aug 06, 2010
MISSION SALIVA ALCOHOL TEST STRIP
K093879 · DIC
Toxicology · 231d
Cleared Jan 28, 2010
MISSION BREATH ALCOHOL DETECTOR
K093143 · DJZ
Toxicology · 115d
Cleared Oct 12, 2007
ACON UTI URINARY TRACT INFECTION TEST STRIPS
K063295 · LJX
Chemistry · 345d
Cleared Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · KQO
Chemistry · 118d
Cleared Feb 02, 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · FLL
General Hospital · 81d
Cleared May 09, 2006
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER,...
K060925 · DXN
Cardiovascular · 35d
Cleared Apr 21, 2006
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP...
K060466 · DJG
Toxicology · 58d
Cleared Mar 17, 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE...
K060173 · FLL
General Hospital · 53d
Cleared Jun 24, 2005
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA...
K050936 · LDJ
Toxicology · 71d
Cleared Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · LDJ
Chemistry · 63d
Cleared May 20, 2005
ACON +/- MIDSTREAM PREGNANCY TEST
K050546 · LCX
Chemistry · 79d
Cleared May 06, 2005
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · DIS
Toxicology · 59d
Cleared Mar 11, 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · LDJ
Toxicology · 60d
Cleared Feb 28, 2005
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272 · KTN
Immunology · 189d
Cleared Feb 25, 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · DJG
Toxicology · 67d
Cleared Sep 16, 2004
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822 · DKZ
Chemistry · 72d
Cleared Sep 09, 2004
ACON TRI-FECT DRUG SCREEN TEST DEVICE
K041743 · DKZ
Toxicology · 73d
Cleared Sep 09, 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · LCX
Chemistry · 31d

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