FDA 510(k)

CAPTIA(R) SYPHILIS M, MODIFICATION

K-Number: K904524 · 1990-12-26

Decision Date1990-12-26

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CAPTIA(R) SYPHILIS M, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Mercia Diagnostics , Ltd.. It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K904524. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPTIA(R) SYPHILIS M, MODIFICATION?

CAPTIA(R) SYPHILIS M, MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Mercia Diagnostics , Ltd.. The 510(k) number is K904524.

When did CAPTIA(R) SYPHILIS M, MODIFICATION receive FDA 510(k) clearance?

CAPTIA(R) SYPHILIS M, MODIFICATION received FDA 510(k) clearance on 1990-12-26, under 510(k) number K904524.

Who is the listed applicant for CAPTIA(R) SYPHILIS M, MODIFICATION?

The FDA 510(k) record lists Mercia Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPTIA(R) SYPHILIS M, MODIFICATION?

The FDA product code for CAPTIA(R) SYPHILIS M, MODIFICATION is LIP.

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Other records listing Mercia Diagnostics , Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.