SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
FDA 510(k) clearance K882767 · decided 1988-07-18
Clearance details
- K-number
- K882767
- Device name
- SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
- Applicant
- Toa Medical Electronics USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-06
- Decision date
- 1988-07-18
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- GKH
- Device class
- 1
- Regulation number
- 864.5240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Los Alamitos, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512) | Immunicon Corp. | 2002-09-30 |
| COULTER CELLPREP (K021150) | Beckman Coulter, Inc. | 2002-06-11 |
| COULTER MULTI Q PREP (K935953) | Coulter Corp. | 1994-03-11 |
| COULTER MULTI-Q-PREP (K923530) | Coulter Electronics, Inc. | 1992-10-14 |
| FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (K904795) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-31 |
| AD150, AUTOMATED HEMATOLOGY DILUTOR (K852373) | Abbott Diagnostics | 1985-07-05 |
| HYCEL DILUTOR, VARIOUS MODELS/MULTI (K842747) | R&D Systems, Inc. | 1984-10-01 |
| DILU-MATIC 140 (K842446) | Abbott Diagnostics | 1984-09-06 |
| DILULAB 230 (K823522) | Innovative Medical Systems, Inc. | 1982-12-28 |
| ROYCO MODEL 371 SUPER DILUTOR (K791644) | Royco Instruments | 1979-09-19 |
Recalls involving this device
No recalls on record reference this clearance.