FDA 510(k)

VACUETTE HOLDEX

K-Number: K980768 · 1998-04-09

Decision Date1998-04-09

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VACUETTE HOLDEX is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Meditech, Inc.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K980768. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUETTE HOLDEX?

VACUETTE HOLDEX is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Greiner Meditech, Inc.. The 510(k) number is K980768.

When did VACUETTE HOLDEX receive FDA 510(k) clearance?

VACUETTE HOLDEX received FDA 510(k) clearance on 1998-04-09, under 510(k) number K980768.

Who is the listed applicant for VACUETTE HOLDEX?

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

What is the FDA product code for VACUETTE HOLDEX?

The FDA product code for VACUETTE HOLDEX is FMI.

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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.