ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
FDA 510(k) clearance K780946 · decided 1978-07-27
Clearance details
- K-number
- K780946
- Device name
- ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
- Applicant
- Hycel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-09
- Decision date
- 1978-07-27
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JPJ
- Device class
- 2
- Regulation number
- 864.5300
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| QBC SYSTEM MCHC (K904675) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-11-02 |
| JTB 700 HEMATOLOGY ANALYZER (K761304) | J.T. Baker Chemical Co. | 1977-02-01 |
Recalls involving this device
No recalls on record reference this clearance.