GKH · Apparatus, Automated Blood Cell Diluting
Hematology · 21 CFR 864.5240 · Class 1
Overview
| Product Code | GKH |
|---|---|
| Device Name | Apparatus, Automated Blood Cell Diluting |
| Regulation | 21 CFR 864.5240 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | Veridex, LLC | Aug 26, 2010 | SESE |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Immunicon Corp. | Mar 12, 2004 | SESE |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Immunicon Corp. | Sep 30, 2002 | SESE |
| K021150 | COULTER CELLPREP | Beckman Coulter, Inc. | Jun 11, 2002 | SESE |
| K935953 | COULTER MULTI Q PREP | Coulter Corp. | Mar 11, 1994 | SESE |
| K923530 | COULTER MULTI-Q-PREP | Coulter Electronics, Inc. | Oct 14, 1992 | SESE |
| K904795 | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 31, 1990 | SESE |
| K882767 | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | Toa Medical Electronics USA, Inc. | Jul 18, 1988 | SESE |
| K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR | Abbott Diagnostics | Jul 5, 1985 | SESE |
| K842747 | HYCEL DILUTOR, VARIOUS MODELS/MULTI | R&D Systems, Inc. | Oct 1, 1984 | SESE |
| K842446 | DILU-MATIC 140 | Abbott Diagnostics | Sep 6, 1984 | SESE |
| K823522 | DILULAB 230 | Innovative Medical Systems, Inc. | Dec 28, 1982 | SESE |
| K791644 | ROYCO MODEL 371 SUPER DILUTOR | Royco Instruments | Sep 19, 1979 | SESE |
| K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE | Ortho Diagnostics, Inc. | Feb 7, 1977 | SESE |
Top Applicants
- Abbott Diagnostics — 2 clearances
- Immunicon Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Coulter Corp. — 1 clearance
