Medical Device Manufacturer · US , Fairfield , NJ

Schiapparelli Biosystems, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1993
24
Total
24
Cleared
0
Denied

FDA 510(k) Regulatory Record - Schiapparelli Biosystems, Inc. Chemistry

20 devices
1-20 of 20
Cleared Jul 13, 1999
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · MRR
Chemistry · 53d
Cleared Jun 10, 1998
ACE T UPTAKE REAGENT TU CALIBRATORS
K981375 · KHQ
Chemistry · 55d
Cleared Jun 10, 1998
ACE T4 REAGENT T4 CALIBRATORS
K981377 · KLI
Chemistry · 55d
Cleared Nov 06, 1997
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
K973536 · DLJ
Chemistry · 49d
Cleared Oct 20, 1997
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · KLT
Chemistry · 32d
Cleared May 21, 1997
ACE HDL-C REAGENT
K971526 · LBS
Chemistry · 23d
Cleared Dec 11, 1995
HDL PRECIPITATING REAGENT
K954179 · LBR
Chemistry · 96d
Cleared Oct 23, 1995
TRIGLYCERIDES REAGENT
K954187 · JGY
Chemistry · 47d
Cleared Aug 07, 1995
MAGNESIUM REAGENT
K952426 · JGJ
Chemistry · 75d
Cleared May 16, 1995
ACE(TM) CEDIA(R) FERRITIN ASSAY
K950393 · JMG
Chemistry · 104d
Cleared May 15, 1995
ACE AMYLASE REAGENT
K951548 · JFJ
Chemistry · 41d
Cleared Feb 10, 1995
ACE IRON REAGENT
K944911 · JIY
Chemistry · 128d
Cleared Dec 28, 1994
ACE(TM) CEDIA(R) PHENYTOIN ASSAY
K944085 · DIP
Chemistry · 128d
Cleared Nov 28, 1994
ACE CEDIA CORTISOL ASSAY
K943427 · CGR
Chemistry · 136d
Cleared Oct 06, 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · DLZ
Chemistry · 135d
Cleared Jul 18, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · DIS
Chemistry · 112d
Cleared May 03, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · KXT
Chemistry · 102d
Cleared Oct 12, 1993
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
K933862 · JGS
Chemistry · 64d
Cleared Sep 21, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K931786 · JJE
Chemistry · 165d
Cleared Aug 23, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K930104 · JIX
Chemistry · 224d
Filters