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FDA 510(k)

LP(A) CALIBRATORS, AND LP(A) CONTROLS

K-Number: K132400 · 2013-12-19

ApplicantBiokit, S.A.
Decision Date2013-12-19
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LP(A) CALIBRATORS, AND LP(A) CONTROLS 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 2013-12-19 under 510(k) number K132400. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LP(A) CALIBRATORS, AND LP(A) CONTROLS?

LP(A) CALIBRATORS, AND LP(A) CONTROLS is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is Biokit, S.A.. The 510(k) number is K132400.

When did LP(A) CALIBRATORS, AND LP(A) CONTROLS receive FDA 510(k) clearance?

LP(A) CALIBRATORS, AND LP(A) CONTROLS received FDA 510(k) clearance on 2013-12-19, under 510(k) number K132400.

Who is the listed applicant for LP(A) CALIBRATORS, AND LP(A) CONTROLS?

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 LP(A) CALIBRATORS, AND LP(A) CONTROLS?

The FDA product code for LP(A) CALIBRATORS, AND LP(A) CONTROLS is JIT.

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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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