FDA 510(k)

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166

K-Number: K060375 · 2006-06-06

Decision Date2006-06-06

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Biosciences. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K060375. 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 MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166?

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Bd Biosciences. The 510(k) number is K060375.

When did BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 receive FDA 510(k) clearance?

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 received FDA 510(k) clearance on 2006-06-06, under 510(k) number K060375.

Who is the listed applicant for BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166?

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 MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166?

The FDA product code for BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 is GKZ.

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Other records listing Bd Biosciences as applicant

K090967BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 K081213BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 K071143BD TRITEST CD3/CD4/CD45, MODEL 340383 K071141BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 K062087BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 K041074BD FACSCANTO WITH BD FACSANTO SOFTWARE

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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.