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CAPTIA SYPHILIS-G ELISA TEST SYSTEM

FDA 510(k) clearance K001525 · decided 2000-11-29

Clearance details

K-number
K001525
Device name
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
Applicant
Trinity Biotech, Plc
Decision
Substantially Equivalent
Date received
2000-05-16
Decision date
2000-11-29
Days to decision
197 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Jamestown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.