Schiapparelli Biosystems, Inc.
Medical device manufacturer in Fairfield, NJ.
24510(k) clearances
0PMA approvals
0recalls
Device types
- DIP Enzyme Immunoassay, Diphenylhydantoin 2
- JMG Radioimmunoassay (Two-Site Solid Phase)… 1
- MRR System, Test, Low Density, Lipoprotein 1
- KLS Enzyme Immunoassay, Theophylline 1
- DJD Enzyme Immunoassay, Primidone 1
- LEG Enzyme Immunoassay, Valproic Acid 1
- DLJ Calibrators, Drug Specific 1
- KLT Enzyme Immunoassay, Carbamazepine 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- JGY Colorimetric Method, Triglycerides 1
- JGJ Photometric Method, Magnesium 1
- JIX Calibrator, Multi-Analyte Mixture 1
- JFJ Catalytic Methods, Amylase 1
- JIY Photometric Method, Iron (Non-Heme) 1
- CGR Radioimmunoassay, Cortisol 1
- DLZ Enzyme Immunoassay, Phenobarbital 1
- DIS Enzyme Immunoassay, Barbiturate 1
- KXT Enzyme Immunoassay, Digoxin 1
- JGS Electrode, Ion Specific, Sodium 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K991733 | Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional | 07/13/1999SE |
| K981377 | Ace T4 Reagent T4 CalibratorsKLI · Traditional | 06/10/1998SE |
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | 06/10/1998SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | 11/12/1997SE |
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | 11/12/1997SE |
| K973581 | Ace Valproic Acid Reagent, AED CalibratorsLEG · Traditional | 11/12/1997SE |
| K973536 | Ace Phenobarbital Reagent/Aed CalibratorsDLJ · Traditional | 11/06/1997SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | 11/04/1997SE |
| K973535 | Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional | 10/20/1997SE |
| K971526 | Ace Hdl-C ReagentLBS · Traditional | 05/21/1997SE |
| K954179 | HDL Precipitating ReagentLBR · Traditional | 12/11/1995SE |
| K954187 | Triglycerides ReagentJGY · Traditional | 10/23/1995SE |
| K952426 | Magnesium ReagentJGJ · Traditional | 08/07/1995SE |
| K950393 | Ace(Tm) Cedia(R) Ferritin AssayJMG · Traditional | 05/16/1995SE |
| K951548 | Ace Amylase ReagentJFJ · Traditional | 05/15/1995SE |
| K944911 | Ace Iron ReagentJIY · Traditional | 02/10/1995SE |
| K944085 | Ace(Tm) Cedia(R) Phenytoin AssayDIP · Traditional | 12/28/1994SE |
| K943427 | Ace Cedia Cortisol AssayCGR · Traditional | 11/28/1994SE |
| K942501 | Ace Cedia Phenobarbital AssayDLZ · Traditional | 10/06/1994SE |
| K941489 | Ace Clinical Chemistry SystemDIS · Traditional | 07/18/1994SE |
| K940267 | Ace Clinical Chemistry SystemKXT · Traditional | 05/03/1994SE |
| K933862 | Ace(Tm) Clin Chem Syst W/Opt Ion Select Electr(Ise)JGS · Traditional | 10/12/1993SE |
| K931786 | Ace Clinical Chemistry SystemJJE · Traditional | 09/21/1993SE |
| K930104 | Ace Clinical Chemistry SystemJIX · Traditional | 08/23/1993SE |