PLATELET RETENTION (ADHESION) COLUMNS
FDA 510(k) clearance K800037 · decided 1980-02-05
Clearance details
- K-number
- K800037
- Device name
- PLATELET RETENTION (ADHESION) COLUMNS
- Applicant
- Hemometrix
- Decision
- Substantially Equivalent
- Date received
- 1980-01-07
- Decision date
- 1980-02-05
- Days to decision
- 29 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 |
|---|---|---|
| THROMBO-SCREEN PLATELET ADHESION (K771678) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-11-22 |
| LATELET RETENTION COLUMN (K771523) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-22 |
Recalls involving this device
No recalls on record reference this clearance.