Schiapparelli Biosystems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 24
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | July 13, 1999 |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | June 10, 1998 |
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | June 10, 1998 |
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | November 12, 1997 |
| K973581 | ACE VALPROIC ACID REAGENT, AED CALIBRATORS | November 12, 1997 |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | November 12, 1997 |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | November 6, 1997 |
| K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS | November 4, 1997 |
| K973535 | ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS | October 20, 1997 |
| K971526 | ACE HDL-C REAGENT | May 21, 1997 |
| K954179 | HDL PRECIPITATING REAGENT | December 11, 1995 |
| K954187 | TRIGLYCERIDES REAGENT | October 23, 1995 |
| K952426 | MAGNESIUM REAGENT | August 7, 1995 |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | May 16, 1995 |
| K951548 | ACE AMYLASE REAGENT | May 15, 1995 |
| K944911 | ACE IRON REAGENT | February 10, 1995 |
| K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | December 28, 1994 |
| K943427 | ACE CEDIA CORTISOL ASSAY | November 28, 1994 |
| K942501 | ACE CEDIA PHENOBARBITAL ASSAY | October 6, 1994 |
| K941489 | ACE CLINICAL CHEMISTRY SYSTEM | July 18, 1994 |