Product code GKG
- Device name
- Centrifuge, Hematocrit
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.6400
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961803 | SPUNCRIT (MODEL DRC-40) | Micro Diagnostics Corp. | 1996-07-05 |
| K955795 | MULTI-CENTRIFUGE | Novonx, Inc. | 1996-03-29 |
| K930415 | MICROHEMATOCRIT ROTOR | Fisher Scientific Co., LLC | 1993-03-23 |
| K925863 | SPUNCRIT | bioMerieux, Inc. | 1993-02-05 |
| K920207 | HERMLE Z230H | Labnet Intl., Inc. | 1992-06-09 |
| K920759 | CRITSPIN MICRO-HEMATOCRIT | Stat-Spin Technologies | 1992-04-29 |
| K913128 | HEMATASTAT C-70B | Separation Technology, Inc. | 1991-09-23 |
| K890849 | HEMATASTAT H-70 | Separation Technology, Inc. | 1989-03-21 |
| K821803 | QBC CENTRIFUGAL HEMATOLOGY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-14 |
| K822445 | HCT CENTRIFUGE | Boehringer Mannheim Corp. | 1982-09-14 |
| K813033 | CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00831829000441 | 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg) | SEPARATION TECHNOLOGY, INC. | 2023-11-06 |
| 00831829000458 | 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg) | SEPARATION TECHNOLOGY, INC. | 2023-11-06 |
| 00840095655699 | Globe Scientific | GLOBE SCIENTIFIC INC. | 2023-07-05 |
| 00664816005668 | LW Scientific, Inc. | LW SCIENTIFIC, INC. | 2023-01-30 |
| 00664816005651 | LW Scientific, Inc. | LW SCIENTIFIC, INC. | 2023-01-30 |
| 00664816005309 | LW Scientific, Inc. | LW SCIENTIFIC, INC. | 2022-10-25 |
| 00664816005576 | LW Scientific, Inc. | LW SCIENTIFIC, INC. | 2022-09-09 |
| 00664816005613 | LW Scientific, Inc. | LW SCIENTIFIC, INC. | 2022-09-09 |
| 40612479200102 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2022-08-31 |
| 00304040043370 | Henry Schein | HENRY SCHEIN, INC. | 2022-05-03 |
| 00831829000410 | HemataSTAT II Centrifuge | SEPARATION TECHNOLOGY, INC. | 2022-03-31 |
| 04050674077149 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674068369 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674026772 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674026383 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674026345 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674026338 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674026284 | Bucket | Andreas Hettich GmbH | 2021-09-03 |
| 04050674027663 | Angle rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674027748 | Angle rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674027830 | Angle rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674027854 | Angle rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674028318 | Angle rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674028325 | Angle rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674030076 | Swing-out rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674030151 | Swing-out rotor | Andreas Hettich GmbH | 2021-09-02 |
| 04050674030380 | Swing-out rotor | Andreas Hettich GmbH | 2021-09-02 |
| 00856522006033 | H4 Cartridge | Lifehealth | 2016-09-24 |
| 00856522006026 | H3 Cartridge | Lifehealth | 2016-09-24 |
| M368410E1 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |