FDA 510(k)

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM

K-Number: K091361 · 2009-12-16

Decision Date2009-12-16

Product CodeLIP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2009-12-16 under 510(k) number K091361. 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 IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM?

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-16. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K091361.

When did IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM receive FDA 510(k) clearance?

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM received FDA 510(k) clearance on 2009-12-16, under 510(k) number K091361.

Who is the listed applicant for IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM?

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

What is the FDA product code for IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM?

The FDA product code for IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM 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.