CYTO-TEK CENTRIFUGE
FDA 510(k) clearance K852117 · decided 1985-06-10
Clearance details
- K-number
- K852117
- Device name
- CYTO-TEK CENTRIFUGE
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-15
- Decision date
- 1985-06-10
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- IFB
- Device class
- 1
- Regulation number
- 864.3300
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Elkhart, IN, 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 |
|---|---|---|
| CYTOBUCKET MODEL 1024 (K810848) | Cytochem, Inc. | 1981-04-23 |
| LEIF CENTRIFUGAL CYTOLOGY BUCKET (K792032) | Robert C. Leif, Ph.D. | 1979-11-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |