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FDA 510(k)

POLLER CALIBRANTS

K-Number: K991439 · 1999-12-20

ApplicantEuropean Concerted Action on Anticoagulation
Decision Date1999-12-20
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POLLER CALIBRANTS is the device name listed in this FDA 510(k) record. The listed applicant is European Concerted Action on Anticoagulation. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K991439. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLLER CALIBRANTS?

POLLER CALIBRANTS is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is European Concerted Action on Anticoagulation. The 510(k) number is K991439.

When did POLLER CALIBRANTS receive FDA 510(k) clearance?

POLLER CALIBRANTS received FDA 510(k) clearance on 1999-12-20, under 510(k) number K991439.

Who is the listed applicant for POLLER CALIBRANTS?

The FDA 510(k) record lists European Concerted Action on Anticoagulation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLLER CALIBRANTS?

The FDA product code for POLLER CALIBRANTS is GGN.

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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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