Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schiapparelli Biosystems, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
136 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | Schiapparelli Biosystems, Inc. | 1999-07-13 | 53 | 0 |
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 | 55 | 0 |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Schiapparelli Biosystems, Inc. | 1998-06-10 | 55 | 0 |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 | 51 | 0 |
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 | 51 | 0 |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 | 51 | 0 |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-06 | 49 | 0 |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-04 | 56 | 0 |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-10-20 | 32 | 0 |
| K971526 | ACE HDL-C REAGENT | Schiapparelli Biosystems, Inc. | 1997-05-21 | 23 | 0 |
| K954179 | HDL PRECIPITATING REAGENT | Schiapparelli Biosystems, Inc. | 1995-12-11 | 96 | 0 |
| K954187 | TRIGLYCERIDES REAGENT | Schiapparelli Biosystems, Inc. | 1995-10-23 | 47 | 0 |
| K952426 | MAGNESIUM REAGENT | Schiapparelli Biosystems, Inc. | 1995-08-07 | 75 | 0 |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | 1995-05-16 | 104 | 0 |
| K951548 | ACE AMYLASE REAGENT | Schiapparelli Biosystems, Inc. | 1995-05-15 | 41 | 0 |
| K944911 | ACE IRON REAGENT | Schiapparelli Biosystems, Inc. | 1995-02-10 | 128 | 0 |
| K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | Schiapparelli Biosystems, Inc. | 1994-12-28 | 128 | 0 |
| K943427 | ACE CEDIA CORTISOL ASSAY | Schiapparelli Biosystems, Inc. | 1994-11-28 | 136 | 0 |
| K942501 | ACE CEDIA PHENOBARBITAL ASSAY | Schiapparelli Biosystems, Inc. | 1994-10-06 | 135 | 0 |
| K941489 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1994-07-18 | 112 | 0 |
| K940267 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1994-05-03 | 102 | 0 |
| K933862 | ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) | Schiapparelli Biosystems, Inc. | 1993-10-12 | 64 | 0 |
| K931786 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1993-09-21 | 165 | 0 |
| K930104 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1993-08-23 | 224 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda