DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
FDA 510(k) clearance K932876 · decided 1993-11-15
Clearance details
- K-number
- K932876
- Device name
- DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
- Applicant
- Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-14
- Decision date
- 1993-11-15
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- LKJ
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antib recall (Z-0306-2018) | Euro Diagnostica AB | 2017-12-20 |