RAPID IMMUNO-ASSAY SYS
FDA 510(k) clearance K840257 · decided 1984-04-19
Clearance details
- K-number
- K840257
- Device name
- RAPID IMMUNO-ASSAY SYS
- Applicant
- Applied Polytechnology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-01-23
- Decision date
- 1984-04-19
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- LLG
- Device class
- 2
- Regulation number
- 864.5425
- 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 |
|---|---|---|
| GENERAL DIAGNOSTICS PLATELET ANTIBODY (K841465) | General Diagnostics | 1984-07-02 |
Recalls involving this device
No recalls on record reference this clearance.