FDA 510(k)

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

K-Number: K063643 · 2006-12-27

ApplicantBio-Rad Laboratories Inc., Clinical Systems Divisi

Decision Date2006-12-27

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM 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 2006-12-27 under 510(k) number K063643. 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 MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM?

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM is a medical device that received FDA 510(k) clearance on 2006-12-27. The listed applicant is Bio-Rad Laboratories Inc., Clinical Systems Divisi. The 510(k) number is K063643.

When did MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM receive FDA 510(k) clearance?

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM received FDA 510(k) clearance on 2006-12-27, under 510(k) number K063643.

Who is the listed applicant for MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM?

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 MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM?

The FDA product code for MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM is LCP.

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Other records listing Bio-Rad Laboratories Inc., Clinical Systems Divisi as applicant

K080911VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH K070819VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

Related Devices (Code: 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.