FastPack IP Sex Hormone Binding Globulin Immunoassay
FDA 510(k) clearance K182521 · decided 2019-01-29
Clearance details
- K-number
- K182521
- Device name
- FastPack IP Sex Hormone Binding Globulin Immunoassay
- Applicant
- Qualigen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-13
- Decision date
- 2019-01-29
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quant recall (Z-0805-2025) | Qualigen Inc | 2025-01-03 |