ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
FDA 510(k) clearance K201438 · decided 2020-10-21
Clearance details
- K-number
- K201438
- Device name
- ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
- Applicant
- Arlington Scientific, Inc. (Asi)
- Decision
- Substantially Equivalent
- Date received
- 2020-06-01
- Decision date
- 2020-10-21
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GMQ
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Springville, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.