MODIFIED CAPTIA(R) SYPHILIS-M

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

MERCIA DIAGNOSTICS LTD.

The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Modified Captia(r) Syphilis-m.

Pre-market Notification Details

Device IDK900654
510k NumberK900654
Device Name:MODIFIED CAPTIA(R) SYPHILIS-M
ClassificationEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England,  GB Gu4 8ew
ContactLewis, Phd
CorrespondentLewis, Phd
MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England,  GB Gu4 8ew
Product CodeLIP  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-09
Decision Date1990-03-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.