Medical Device Manufacturer · US , Fairfield , NJ

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

24 submissions · 24 cleared · Since 1993

Recent clearances: ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS, ACE T UPTAKE REAGENT TU CALIBRATORS, ACE T4 REAGENT T4 CALIBRATORS

24

Total

24

Cleared

0

Denied

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

20 devices

1-12 of 20

Cleared Jul 13, 1999

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

Chemistry · 53d

Cleared Jun 10, 1998

ACE T UPTAKE REAGENT TU CALIBRATORS

Chemistry · 55d

Cleared Jun 10, 1998

ACE T4 REAGENT T4 CALIBRATORS

Chemistry · 55d

Cleared Nov 06, 1997

ACE PHENOBARBITAL REAGENT/AED CALIBRATORS

Chemistry · 49d

Cleared Oct 20, 1997

ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS

Chemistry · 32d

Cleared May 21, 1997

ACE HDL-C REAGENT

Chemistry · 23d

Cleared Dec 11, 1995

HDL PRECIPITATING REAGENT

Chemistry · 96d

Cleared Oct 23, 1995

TRIGLYCERIDES REAGENT

Chemistry · 47d

Cleared Aug 07, 1995

MAGNESIUM REAGENT

Chemistry · 75d

Cleared May 16, 1995

ACE(TM) CEDIA(R) FERRITIN ASSAY

Chemistry · 104d

Cleared May 15, 1995

ACE AMYLASE REAGENT

Chemistry · 41d

Cleared Feb 10, 1995

ACE IRON REAGENT

Chemistry · 128d