Company ยท US
Schiapparelli Biosystems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1999. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 2 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| DJD | Enzyme Immunoassay, Primidone | 1 |
| DLJ | Calibrators, Drug Specific | 1 |
| DLZ | Enzyme Immunoassay, Phenobarbital | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 1999 | K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS Schiapparelli Biosystems, Inc. | MRR |
| Jun 10, 1998 | K981377 | ACE T4 REAGENT T4 CALIBRATORS Schiapparelli Biosystems, Inc. | KLI |
| Jun 10, 1998 | K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS Schiapparelli Biosystems, Inc. | KHQ |
| Nov 12, 1997 | K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS Schiapparelli Biosystems, Inc. | KLS |
| Nov 12, 1997 | K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS Schiapparelli Biosystems, Inc. | DJD |
| Nov 12, 1997 | K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS Schiapparelli Biosystems, Inc. | LEG |
| Nov 6, 1997 | K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS Schiapparelli Biosystems, Inc. | DLJ |
| Nov 4, 1997 | K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS Schiapparelli Biosystems, Inc. | DIP |
| Oct 20, 1997 | K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS Schiapparelli Biosystems, Inc. | KLT |
| May 21, 1997 | K971526 | ACE HDL-C REAGENT Schiapparelli Biosystems, Inc. | LBS |
| Dec 11, 1995 | K954179 | HDL PRECIPITATING REAGENT Schiapparelli Biosystems, Inc. | LBR |
| Oct 23, 1995 | K954187 | TRIGLYCERIDES REAGENT Schiapparelli Biosystems, Inc. | JGY |
| Aug 7, 1995 | K952426 | MAGNESIUM REAGENT Schiapparelli Biosystems, Inc. | JGJ |
| May 16, 1995 | K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY Schiapparelli Biosystems, Inc. | JMG |
| May 15, 1995 | K951548 | ACE AMYLASE REAGENT Schiapparelli Biosystems, Inc. | JFJ |
| Feb 10, 1995 | K944911 | ACE IRON REAGENT Schiapparelli Biosystems, Inc. | JIY |
| Dec 28, 1994 | K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY Schiapparelli Biosystems, Inc. | DIP |
| Nov 28, 1994 | K943427 | ACE CEDIA CORTISOL ASSAY Schiapparelli Biosystems, Inc. | CGR |
| Oct 6, 1994 | K942501 | ACE CEDIA PHENOBARBITAL ASSAY Schiapparelli Biosystems, Inc. | DLZ |
| Jul 18, 1994 | K941489 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | DIS |
| May 3, 1994 | K940267 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | KXT |
| Oct 12, 1993 | K933862 | ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE) Schiapparelli Biosystems, Inc. | JGS |
| Sep 21, 1993 | K931786 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | JJE |
| Aug 23, 1993 | K930104 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | JIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||