CL DETECT RAPID TEST
FDA 510(k) clearance K141341 · decided 2014-11-14
Clearance details
- K-number
- K141341
- Device name
- CL DETECT RAPID TEST
- Applicant
- InBios International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-21
- Decision date
- 2014-11-14
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- PIT
- Device class
- 1
- Regulation number
- 866.3870
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.