COMBI SCAN100
FDA 510(k) clearance K061846 · decided 2007-04-06
Clearance details
- K-number
- K061846
- Device name
- COMBI SCAN100
- Applicant
- Analyticon Biotechnologies AG
- Decision
- Substantially Equivalent
- Date received
- 2006-06-26
- Decision date
- 2007-04-06
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- JIL
- Device class
- 2
- Regulation number
- 862.1340
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lichtenfels, Hessen, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.