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FDA 510(k)

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010

K-Number: K081213 · 2008-08-14

ApplicantBd Biosciences
Decision Date2008-08-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Biosciences. It received FDA 510(k) clearance on 2008-08-14 under 510(k) number K081213. 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 FACSCOUNT CD4 REAGENTS WITH MODEL 339010?

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 is a medical device that received FDA 510(k) clearance on 2008-08-14. The listed applicant is Bd Biosciences. The 510(k) number is K081213.

When did BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 receive FDA 510(k) clearance?

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 received FDA 510(k) clearance on 2008-08-14, under 510(k) number K081213.

Who is the listed applicant for BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010?

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 FACSCOUNT CD4 REAGENTS WITH MODEL 339010?

The FDA product code for BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 is GKZ.

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Other records listing Bd Biosciences as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090967BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611K071143BD TRITEST CD3/CD4/CD45, MODEL 340383K071141BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402K062087BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962K060375BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166K041074BD FACSCANTO WITH BD FACSANTO SOFTWARE

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

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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