FDA 510(k)

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

K-Number: K070819 · 2007-06-25

ApplicantBio-Rad Laboratories Inc., Clinical Systems Divisi

Decision Date2007-06-25

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories Inc., Clinical Systems Divisi. It received FDA 510(k) clearance on 2007-06-25 under 510(k) number K070819. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,?

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, is a medical device that received FDA 510(k) clearance on 2007-06-25. The listed applicant is Bio-Rad Laboratories Inc., Clinical Systems Divisi. The 510(k) number is K070819.

When did VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, receive FDA 510(k) clearance?

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, received FDA 510(k) clearance on 2007-06-25, under 510(k) number K070819.

Who is the listed applicant for VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,?

The FDA 510(k) record lists Bio-Rad Laboratories Inc., Clinical Systems Divisi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,?

The FDA product code for VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, is LCP.

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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.