PLATELET AGGREGATING REAGENTS
FDA 510(k) clearance K780047 · decided 1978-03-02
Clearance details
- K-number
- K780047
- Device name
- PLATELET AGGREGATING REAGENTS
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-09
- Decision date
- 1978-03-02
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- JOZ
- Device class
- 2
- Regulation number
- 864.5700
- 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
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Recalls involving this device
No recalls on record reference this clearance.