MICROHEMATOCRIT ROTOR
FDA 510(k) clearance K930415 · decided 1993-03-23
Clearance details
- K-number
- K930415
- Device name
- MICROHEMATOCRIT ROTOR
- Applicant
- Fisher Scientific Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 1993-01-26
- Decision date
- 1993-03-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GKG
- Device class
- 2
- Regulation number
- 864.6400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPUNCRIT (MODEL DRC-40) (K961803) | Micro Diagnostics Corp. | 1996-07-05 |
| MULTI-CENTRIFUGE (K955795) | Novonx, Inc. | 1996-03-29 |
| SPUNCRIT (K925863) | bioMerieux, Inc. | 1993-02-05 |
| HERMLE Z230H (K920207) | Labnet Intl., Inc. | 1992-06-09 |
| CRITSPIN MICRO-HEMATOCRIT (K920759) | Stat-Spin Technologies | 1992-04-29 |
| HEMATASTAT C-70B (K913128) | Separation Technology, Inc. | 1991-09-23 |
| HEMATASTAT H-70 (K890849) | Separation Technology, Inc. | 1989-03-21 |
| HCT CENTRIFUGE (K822445) | Boehringer Mannheim Corp. | 1982-09-14 |
| QBC CENTRIFUGAL HEMATOLOGY SYSTEM (K821803) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-09-14 |
| CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY (K813033) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-04-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001) | Fisher Scientific Co., LLC | 1979-07-18 |