American Bioproducts Co.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 79
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | November 12, 1998 |
| K971519 | ASSERACHROM TPA TEST KIT | August 19, 1997 |
| K964728 | STA-LIATEST D-DI TEST KIT | June 26, 1997 |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | June 26, 1997 |
| K964718 | STA D-DI CALIBRATOR KIT | May 23, 1997 |
| K962675 | STA - LIATEST VWF TEST KIT | October 25, 1996 |
| K962671 | STA-VWF CALIBRATOR KIT | September 13, 1996 |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | July 23, 1996 |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | July 10, 1996 |
| K955040 | AT-III CONTROL PLASMA KIT | January 31, 1996 |
| K954017 | ASSERACHROM FREE PROTEIN S KIT | November 13, 1995 |
| K954040 | ASSERACHROM TOTAL PROTEIN S KIT | November 13, 1995 |
| K943519 | HBPM/LMWH CONTROL KIT | September 26, 1995 |
| K943514 | THE HEPANORM HBPM/LMWH KIT | September 26, 1995 |
| K943520 | HEPARIN CONTROL KIT | September 26, 1995 |
| K952338 | STA-COAG CONTROL [P] PLUS KIT | September 21, 1995 |
| K943516 | ROTACHROM HBPM/LMWH TEST KIT | August 31, 1995 |
| K943515 | ROTACHROM HEPARIN TEST KIT | August 31, 1995 |
| K925433 | THE STACHROM HEPARIN ASSAY KIT | May 23, 1995 |
| K943517 | STACLOT HEPARIN TEST KIT | May 11, 1995 |