THERAPEUTIC APHERESIS SYSTEM
FDA premarket approval P850092 · decided 1986-11-18
Approval details
- PMA number
- P850092
- Trade name
- THERAPEUTIC APHERESIS SYSTEM
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Millipore Corp.
- Date received
- 1985-12-18
- Decision date
- 1986-11-18
- Days to decision
- 335 days
- Decision code
- APWD
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Bedford, MA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (K023892) | Millipore Corp. | 2003-01-17 |
| MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (K013988) | Millipore Corp. | 2002-04-04 |
| MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (K963717) | Millipore Corp. | 1997-06-10 |
| ULTRAFREE-CL (K941326) | Millipore Corp. | 1994-05-27 |
| MILLEX, DUALEX (PLUS, ULTRA) (K934069) | Millipore Corp. | 1994-04-21 |
| WATERS(TM) 996 PDA (K924347) | Millipore Corp. | 1992-12-11 |
| WATERS(TM) LC MODULE I FOR CLINICAL USE (K922388) | Millipore Corp. | 1992-09-11 |
| WATERS 717 AUTOSAMPLER (K920136) | Millipore Corp. | 1992-02-19 |