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FDA 510(k)

DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET

K-Number: K131556 · 2013-06-26

ApplicantDiazyme Laboratories
Decision Date2013-06-26
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2013-06-26 under 510(k) number K131556. 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 DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET?

DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET is a medical device that received FDA 510(k) clearance on 2013-06-26. The listed applicant is Diazyme Laboratories. The 510(k) number is K131556.

When did DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET receive FDA 510(k) clearance?

DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET received FDA 510(k) clearance on 2013-06-26, under 510(k) number K131556.

Who is the listed applicant for DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET?

The FDA 510(k) record lists Diazyme Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET?

The FDA product code for DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET 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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