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FDA 510(k)

IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL

K-Number: K122534 · 2013-03-14

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2013-03-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL 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 2013-03-14 under 510(k) number K122534. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL?

IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K122534.

When did IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL receive FDA 510(k) clearance?

IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL received FDA 510(k) clearance on 2013-03-14, under 510(k) number K122534.

Who is the listed applicant for IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL?

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 IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL?

The FDA product code for IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL is JJX.

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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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