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FDA 510(k)

QUANTIA LA(A)

K-Number: K050487 · 2005-04-26

ApplicantBiokit, S.A.
Decision Date2005-04-26
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIA LA(A) is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2005-04-26 under 510(k) number K050487. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIA LA(A)?

QUANTIA LA(A) is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Biokit, S.A.. The 510(k) number is K050487.

When did QUANTIA LA(A) receive FDA 510(k) clearance?

QUANTIA LA(A) received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050487.

Who is the listed applicant for QUANTIA LA(A)?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIA LA(A)?

The FDA product code for QUANTIA LA(A) is DFC.

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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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