510(k) K791644
- Device
- Royco Model 371 Super Dilutor
- Applicant
- ROYCO INSTRUMENTS
- 510(k) number
- K791644
- Product code
- GKH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-19
- Date received
- 1979-08-23
- Regulation
- 864.5240
- Classification name
- Apparatus, Automated Blood Cell Diluting
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006788232
- 3025460034
- 3014150341
- 3034246178
- 3004153557
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GKH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | Veridex, LLC | 2010-08-26 |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Immunicon Corp. | 2004-03-12 |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Immunicon Corp. | 2002-09-30 |
| K021150 | COULTER CELLPREP | Beckman Coulter, Inc. | 2002-06-11 |
| K935953 | COULTER MULTI Q PREP | Coulter Corp. | 1994-03-11 |
| K923530 | COULTER MULTI-Q-PREP | Coulter Electronics, Inc. | 1992-10-14 |
| K904795 | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-31 |
| K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | Toa Medical Electronics USA, Inc. | 1988-07-18 |
| K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR | Abbott Diagnostics | 1985-07-05 |
| K842747 | HYCEL DILUTOR, VARIOUS MODELS/MULTI | R&D Systems, Inc. | 1984-10-01 |
| K842446 | DILU-MATIC 140 | Abbott Diagnostics | 1984-09-06 |
| K823522 | DILULAB 230 | Innovative Medical Systems, Inc. | 1982-12-28 |
| K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE | Ortho Diagnostics, Inc. | 1977-02-07 |