510(k) K920759
- Device
- Critspin Micro-hematocrit
- Applicant
- STAT-SPIN TECHNOLOGIES
- 510(k) number
- K920759
- Product code
- GKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-29
- Date received
- 1992-02-19
- Regulation
- 864.6400
- Classification name
- Centrifuge, Hematocrit
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS F KELLEY
- Address
- 85 Morse St. Norwood MA US 02062 02062
FDA Registration Numbers#
- 3009155756
- 3012302888
- 3012942167
- 1061932
- 3014150341
- 3011816315
- 2249760
- 3003799895
- 3006697110
- 3006897996
- 2050012
- 3008717264
- 3017065670
- 2244900
- 3043009938
- 3005990076
- 1067123
- 1616487
Source Documents#
Other 510(k) Records For Product Code GKG#
| 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 |
| 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 |