FDA 510(k)

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS

K-Number: K112343 · 2012-01-20

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2012-01-20

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K112343. 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 TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS?

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K112343.

When did TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS receive FDA 510(k) clearance?

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS received FDA 510(k) clearance on 2012-01-20, under 510(k) number K112343.

Who is the listed applicant for TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS?

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

What is the FDA product code for TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS?

The FDA product code for TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS 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.