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FDA 510(k)

MULTIPLATE 5.0 AGGREGOMETER

K-Number: K103555 · 2012-07-27

ApplicantVerum Diagnostica GmbH
Decision Date2012-07-27
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MULTIPLATE 5.0 AGGREGOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Verum Diagnostica GmbH. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K103555. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLATE 5.0 AGGREGOMETER?

MULTIPLATE 5.0 AGGREGOMETER is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Verum Diagnostica GmbH. The 510(k) number is K103555.

When did MULTIPLATE 5.0 AGGREGOMETER receive FDA 510(k) clearance?

MULTIPLATE 5.0 AGGREGOMETER received FDA 510(k) clearance on 2012-07-27, under 510(k) number K103555.

Who is the listed applicant for MULTIPLATE 5.0 AGGREGOMETER?

The FDA 510(k) record lists Verum Diagnostica GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLATE 5.0 AGGREGOMETER?

The FDA product code for MULTIPLATE 5.0 AGGREGOMETER is JOZ.

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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.

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