THROMBO-SCREEN PLATELET ADHESION
FDA 510(k) clearance K771678 · decided 1977-11-22
Clearance details
- K-number
- K771678
- Device name
- THROMBO-SCREEN PLATELET ADHESION
- Applicant
- Bay Area Hema. Onco. Clinic. & Res. L
- Decision
- Substantially Equivalent
- Date received
- 1977-09-02
- Decision date
- 1977-11-22
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- JBZ
- Device class
- 2
- Regulation number
- 864.6650
- 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 |
|---|---|---|
| PLATELET RETENTION (ADHESION) COLUMNS (K800037) | Hemometrix | 1980-02-05 |
| LATELET RETENTION COLUMN (K771523) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-22 |
Recalls involving this device
No recalls on record reference this clearance.