SMART READ BIOLOGICAL TEST PACK
FDA 510(k) clearance K103000 · decided 2011-02-11
Clearance details
- K-number
- K103000
- Device name
- SMART READ BIOLOGICAL TEST PACK
- Applicant
- Steritec Products Mfg Co, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-08
- Decision date
- 2011-02-11
- Days to decision
- 126 days
- Clearance type
- Special
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Engelwood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.