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MODIFIED CAPTIA(R) SYPHILIS-M

FDA 510(k) clearance K900654 · decided 1990-03-08

Clearance details

K-number
K900654
Device name
MODIFIED CAPTIA(R) SYPHILIS-M
Applicant
Mercia Diagnostics , Ltd.
Decision
Substantially Equivalent
Date received
1990-02-09
Decision date
1990-03-08
Days to decision
27 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Guildford, Surrey England, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.