FIAX IGG TEST KIT
FDA 510(k) clearance K831609 · decided 1983-06-17
Clearance details
- K-number
- K831609
- Device name
- FIAX IGG TEST KIT
- Applicant
- Intl. Diagnostic Technology
- Decision
- Substantially Equivalent
- Date received
- 1983-05-18
- Decision date
- 1983-06-17
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DGK
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| RABBIT ANTISERUM TO HUMAN IGG (K831908) | Dako Corp. | 1983-07-18 |
Recalls involving this device
No recalls on record reference this clearance.