SYPHILIS HEALTH CHECK
FDA 510(k) clearance K102400 · decided 2011-08-01
Clearance details
- K-number
- K102400
- Device name
- SYPHILIS HEALTH CHECK
- Applicant
- Diagnostics Direct, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-08-24
- Decision date
- 2011-08-01
- Days to decision
- 342 days
- Clearance type
- Traditional
- Product code
- LIP
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.