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FDA 510(k)

VARIANT SICKLE CELL SHORT PROGRAM

K-Number: K924813 · 1993-01-14

ApplicantBio-Rad
Decision Date1993-01-14
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT SICKLE CELL SHORT PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-01-14 under 510(k) number K924813. 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 SICKLE CELL SHORT PROGRAM?

VARIANT SICKLE CELL SHORT PROGRAM is a medical device that received FDA 510(k) clearance on 1993-01-14. The listed applicant is Bio-Rad. The 510(k) number is K924813.

When did VARIANT SICKLE CELL SHORT PROGRAM receive FDA 510(k) clearance?

VARIANT SICKLE CELL SHORT PROGRAM received FDA 510(k) clearance on 1993-01-14, under 510(k) number K924813.

Who is the listed applicant for VARIANT SICKLE CELL SHORT PROGRAM?

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

What is the FDA product code for VARIANT SICKLE CELL SHORT PROGRAM?

The FDA product code for VARIANT SICKLE CELL SHORT PROGRAM is GKA.

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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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