IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
FDA 510(k) clearance K161831 · decided 2016-11-15
Clearance details
- K-number
- K161831
- Device name
- IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
- Applicant
- Immunodiagnostic Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-05
- Decision date
- 2016-11-15
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- MRG
- Device class
- 2
- Regulation number
- 862.1825
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boldon, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.