FIAX IGG TEST
FDA 510(k) clearance K832821 · decided 1983-10-14
Clearance details
- K-number
- K832821
- Device name
- FIAX IGG TEST
- Applicant
- Intl. Diagnostic Technology
- Decision
- Substantially Equivalent
- Date received
- 1983-08-19
- Decision date
- 1983-10-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DFI
- Device class
- 1
- Regulation number
- 866.5860
- 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 |
|---|---|---|
| CANTROL SPINAL FLUID CONTROL (K854190) | Canyon Diagnostics, Inc. | 1985-11-25 |
| RESOLVE-CSF (K843122) | Isolab, Inc. | 1984-11-30 |
| SOMAS HUMAN SPINAL FLUID CONTROL (K840974) | Somas Medical Industries, Inc. | 1984-04-05 |
Recalls involving this device
No recalls on record reference this clearance.