FDA 510(k)

ENZY-WELL SYPHILIS IGG, MODEL 91106

K-Number: K050590 · 2006-08-10

ApplicantDiesse Diagnostica Senese S.P.A.

Decision Date2006-08-10

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ENZY-WELL SYPHILIS IGG, MODEL 91106 is the device name listed in this FDA 510(k) record. The listed applicant is Diesse Diagnostica Senese S.P.A.. It received FDA 510(k) clearance on 2006-08-10 under 510(k) number K050590. 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 ENZY-WELL SYPHILIS IGG, MODEL 91106?

ENZY-WELL SYPHILIS IGG, MODEL 91106 is a medical device that received FDA 510(k) clearance on 2006-08-10. The listed applicant is Diesse Diagnostica Senese S.P.A.. The 510(k) number is K050590.

When did ENZY-WELL SYPHILIS IGG, MODEL 91106 receive FDA 510(k) clearance?

ENZY-WELL SYPHILIS IGG, MODEL 91106 received FDA 510(k) clearance on 2006-08-10, under 510(k) number K050590.

Who is the listed applicant for ENZY-WELL SYPHILIS IGG, MODEL 91106?

The FDA 510(k) record lists Diesse Diagnostica Senese S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZY-WELL SYPHILIS IGG, MODEL 91106?

The FDA product code for ENZY-WELL SYPHILIS IGG, MODEL 91106 is LIP.

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Official Source

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