AUTOREADER 2
FDA 510(k) clearance K103532 · decided 2011-08-26
Clearance details
- K-number
- K103532
- Device name
- AUTOREADER 2
- Applicant
- Trek Diagnostic Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-12-01
- Decision date
- 2011-08-26
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- LRG
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.