AIA-PACK TGAB ASSAY
FDA 510(k) clearance K981522 · decided 1998-10-08
Clearance details
- K-number
- K981522
- Device name
- AIA-PACK TGAB ASSAY
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-28
- Decision date
- 1998-10-08
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- JZO
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Foster City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AIA-PACK TgAb CONTROL SET recall (Z-2169-2017) | Tosoh Bioscience, Inc. | 2017-05-15 |