Schiapparelli Biosystems, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Schiapparelli Biosystems, Inc.” (first 1993, latest 1999), across 23 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJD | Enzyme Immunoassay, Primidone | 1 | 1 |
| DLJ | Calibrators, Drug Specific | 1 | 1 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
| JGJ | Photometric Method, Magnesium | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 | 1 |
Plus 13 more product codes.
Review panels
- Clinical Chemistry (14)
- Clinical Toxicology (10)
Most recent Schiapparelli Biosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | MRR | 1999-07-13 | 53 |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | KLI | 1998-06-10 | 55 |
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | KHQ | 1998-06-10 | 55 |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | KLS | 1997-11-12 | 51 |
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | DJD | 1997-11-12 | 51 |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | LEG | 1997-11-12 | 51 |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | DLJ | 1997-11-06 | 49 |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | DIP | 1997-11-04 | 56 |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | KLT | 1997-10-20 | 32 |
| K971526 | ACE HDL-C REAGENT | LBS | 1997-05-21 | 23 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Schiapparelli Biosystems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Schiapparelli Biosystems, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Schiapparelli Biosystems, Inc.” (first 1993, latest 1999), across 23 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Schiapparelli Biosystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schiapparelli Biosystems, Inc. is 60 days.
Which FDA product codes appear under Schiapparelli Biosystems, Inc.?
The most frequent FDA product codes under this applicant name are DIP (Enzyme Immunoassay, Diphenylhydantoin, 2); CGR (Radioimmunoassay, Cortisol, 1); DIS (Enzyme Immunoassay, Barbiturate, 1).
Next steps
- See all 24 Schiapparelli Biosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIP, Schiapparelli Biosystems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.