CYTOBUCKET MODEL 1024
FDA 510(k) clearance K810848 · decided 1981-04-23
Clearance details
- K-number
- K810848
- Device name
- CYTOBUCKET MODEL 1024
- Applicant
- Cytochem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-27
- Decision date
- 1981-04-23
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- IFB
- Device class
- 1
- Regulation number
- 864.3300
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| CYTO-TEK CENTRIFUGE (K852117) | Miles Laboratories, Inc. | 1985-06-10 |
| LEIF CENTRIFUGAL CYTOLOGY BUCKET (K792032) | Robert C. Leif, Ph.D. | 1979-11-30 |
Recalls involving this device
No recalls on record reference this clearance.