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FDA 510(k)

SYPHILIS HEALTH CHECK

K-Number: K102400 · 2011-08-01

ApplicantDiagnostics Direct, LLC
Decision Date2011-08-01
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYPHILIS HEALTH CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostics Direct, LLC. It received FDA 510(k) clearance on 2011-08-01 under 510(k) number K102400. 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 SYPHILIS HEALTH CHECK?

SYPHILIS HEALTH CHECK is a medical device that received FDA 510(k) clearance on 2011-08-01. The listed applicant is Diagnostics Direct, LLC. The 510(k) number is K102400.

When did SYPHILIS HEALTH CHECK receive FDA 510(k) clearance?

SYPHILIS HEALTH CHECK received FDA 510(k) clearance on 2011-08-01, under 510(k) number K102400.

Who is the listed applicant for SYPHILIS HEALTH CHECK?

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

What is the FDA product code for SYPHILIS HEALTH CHECK?

The FDA product code for SYPHILIS HEALTH CHECK is LIP.

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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.

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