EIA SMDP IMMUNOASSAY
FDA 510(k) clearance K132631 · decided 2014-08-29
Clearance details
- K-number
- K132631
- Device name
- EIA SMDP IMMUNOASSAY
- Applicant
- Phadia US, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-22
- Decision date
- 2014-08-29
- Days to decision
- 372 days
- Clearance type
- Traditional
- Product code
- LKP
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in recall (Z-0697-2016) | Phadia Ab | 2016-01-28 |