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FDA 510(k)

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL

K-Number: K132391 · 2013-09-20

ApplicantSiemens Helathcare Diagnostics, Inc.
Decision Date2013-09-20
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Helathcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-09-20 under 510(k) number K132391. 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 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL?

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL is a medical device that received FDA 510(k) clearance on 2013-09-20. The listed applicant is Siemens Helathcare Diagnostics, Inc.. The 510(k) number is K132391.

When did IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL receive FDA 510(k) clearance?

IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL received FDA 510(k) clearance on 2013-09-20, under 510(k) number K132391.

Who is the listed applicant for IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL?

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

What is the FDA product code for IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL?

The FDA product code for IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL is JJX.

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Official Source

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