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FDA 510(k)

STA -CALIBRATOR HBPM/LMWH KIT

K-Number: K010350 · 2001-04-09

ApplicantDiagnostica Stago, Inc.
Decision Date2001-04-09
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA -CALIBRATOR HBPM/LMWH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2001-04-09 under 510(k) number K010350. 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 STA -CALIBRATOR HBPM/LMWH KIT?

STA -CALIBRATOR HBPM/LMWH KIT is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K010350.

When did STA -CALIBRATOR HBPM/LMWH KIT receive FDA 510(k) clearance?

STA -CALIBRATOR HBPM/LMWH KIT received FDA 510(k) clearance on 2001-04-09, under 510(k) number K010350.

Who is the listed applicant for STA -CALIBRATOR HBPM/LMWH KIT?

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

What is the FDA product code for STA -CALIBRATOR HBPM/LMWH KIT?

The FDA product code for STA -CALIBRATOR HBPM/LMWH KIT is GGN.

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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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