GENERAL DIAGNOSTICS PLATELET ANTIBODY
FDA 510(k) clearance K841465 · decided 1984-07-02
Clearance details
- K-number
- K841465
- Device name
- GENERAL DIAGNOSTICS PLATELET ANTIBODY
- Applicant
- General Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1984-04-09
- Decision date
- 1984-07-02
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LLG
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, 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 |
|---|---|---|
| RAPID IMMUNO-ASSAY SYS (K840257) | Applied Polytechnology, Inc. | 1984-04-19 |
Recalls involving this device
No recalls on record reference this clearance.