FDA 510(k)

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

K-Number: K062087 · 2006-09-14

Decision Date2006-09-14

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Biosciences. It received FDA 510(k) clearance on 2006-09-14 under 510(k) number K062087. 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 FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962?

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 is a medical device that received FDA 510(k) clearance on 2006-09-14. The listed applicant is Bd Biosciences. The 510(k) number is K062087.

When did BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 receive FDA 510(k) clearance?

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 received FDA 510(k) clearance on 2006-09-14, under 510(k) number K062087.

Who is the listed applicant for BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962?

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

What is the FDA product code for BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962?

The FDA product code for BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 is 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.