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. Toxicology ✕

4 devices

1-4 of 4

Cleared Nov 12, 1997

ACE VALPROIC ACID REAGENT, AED CALIBRATORS

Toxicology · 51d

Cleared Nov 12, 1997

ACE PRIMIDONE REAGENT, AED CALIBRATORS

Toxicology · 51d

Cleared Nov 12, 1997

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS

Toxicology · 51d

Cleared Nov 04, 1997

ACE PHENYTOIN REAGENT, AED CALIBRATORS

Toxicology · 56d