FDA 510(k)

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH

K-Number: K080911 · 2008-05-02

ApplicantBio-Rad Laboratories Inc., Clinical Systems Divisi

Decision Date2008-05-02

Product CodeGKA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH 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 2008-05-02 under 510(k) number K080911. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH?

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Bio-Rad Laboratories Inc., Clinical Systems Divisi. The 510(k) number is K080911.

When did VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH receive FDA 510(k) clearance?

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080911.

Who is the listed applicant for VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH?

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 NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH?

The FDA product code for VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH is GKA.

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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.