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FDA 510(k)

BD FACS SAMPLE PREP ASSISTANT III (SPA III)

K-Number: K102064 · 2011-03-07

ApplicantBecton, Dickinson & CO
Decision Date2011-03-07
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BD FACS SAMPLE PREP ASSISTANT III (SPA III) is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2011-03-07 under 510(k) number K102064. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD FACS SAMPLE PREP ASSISTANT III (SPA III)?

BD FACS SAMPLE PREP ASSISTANT III (SPA III) is a medical device that received FDA 510(k) clearance on 2011-03-07. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K102064.

When did BD FACS SAMPLE PREP ASSISTANT III (SPA III) receive FDA 510(k) clearance?

BD FACS SAMPLE PREP ASSISTANT III (SPA III) received FDA 510(k) clearance on 2011-03-07, under 510(k) number K102064.

Who is the listed applicant for BD FACS SAMPLE PREP ASSISTANT III (SPA III)?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD FACS SAMPLE PREP ASSISTANT III (SPA III)?

The FDA product code for BD FACS SAMPLE PREP ASSISTANT III (SPA III) is GKZ.

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Related Devices (Code: GKZ)

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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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