Schiapparelli Biosystems, Inc.
Fairfield, NJ, US
Schiapparelli Biosystems, Inc. appears in FDA device records in Fairfield, NJ. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Schiapparelli Biosystems, Inc. between 1993 and 1999. The busiest year on record is 1997, with 7. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 6 |
| 1997 | 7 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | MRR | Substantially Equivalent | |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | KLI | Substantially Equivalent | |
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | KHQ | Substantially Equivalent | |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | KLS | Substantially Equivalent | |
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | DJD | Substantially Equivalent | |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | LEG | Substantially Equivalent | |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | DLJ | Substantially Equivalent | |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | DIP | Substantially Equivalent | |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | KLT | Substantially Equivalent | |
| K971526 | ACE HDL-C REAGENT | LBS | Substantially Equivalent | |
| K954179 | HDL PRECIPITATING REAGENT | LBR | Substantially Equivalent | |
| K954187 | TRIGLYCERIDES REAGENT | JGY | Substantially Equivalent | |
| K952426 | MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | JMG | Substantially Equivalent | |
| K951548 | ACE AMYLASE REAGENT | JFJ | Substantially Equivalent | |
| K944911 | ACE IRON REAGENT | JIY | Substantially Equivalent | |
| K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | DIP | Substantially Equivalent | |
| K943427 | ACE CEDIA CORTISOL ASSAY | CGR | Substantially Equivalent | |
| K942501 | ACE CEDIA PHENOBARBITAL ASSAY | DLZ | Substantially Equivalent | |
| K941489 | ACE CLINICAL CHEMISTRY SYSTEM | DIS | Substantially Equivalent | |
| K940267 | ACE CLINICAL CHEMISTRY SYSTEM | KXT | Substantially Equivalent | |
| K933862 | ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) | JGS | Substantially Equivalent | |
| K931786 | ACE CLINICAL CHEMISTRY SYSTEM | JJE | Substantially Equivalent | |
| K930104 | ACE CLINICAL CHEMISTRY SYSTEM | JIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- DLJCalibrators, Drug Specific
- JFJCatalytic Methods, Amylase
- JGYColorimetric Method, Triglycerides
- JGSElectrode, Ion Specific, Sodium
- DISEnzyme Immunoassay, Barbiturate
- KLTEnzyme Immunoassay, Carbamazepine
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DLZEnzyme Immunoassay, Phenobarbital
- DJDEnzyme Immunoassay, Primidone
- KLSEnzyme Immunoassay, Theophylline
- LEGEnzyme Immunoassay, Valproic Acid
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- KHQRadioassay, Triiodothyronine Uptake
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CGRRadioimmunoassay, Cortisol
- MRRSystem, Test, Low Density, Lipoprotein
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain