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FDA 510(k)

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

K-Number: K051072 · 2005-05-12

ApplicantBio-Rad Laboratories, Inc.
Decision Date2005-05-12
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2005-05-12 under 510(k) number K051072. 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 BIO-RAD VARIANT NBS SICKLE CELL PROGRAM?

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM is a medical device that received FDA 510(k) clearance on 2005-05-12. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K051072.

When did BIO-RAD VARIANT NBS SICKLE CELL PROGRAM receive FDA 510(k) clearance?

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM received FDA 510(k) clearance on 2005-05-12, under 510(k) number K051072.

Who is the listed applicant for BIO-RAD VARIANT NBS SICKLE CELL PROGRAM?

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

What is the FDA product code for BIO-RAD VARIANT NBS SICKLE CELL PROGRAM?

The FDA product code for BIO-RAD VARIANT NBS SICKLE CELL PROGRAM 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.

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