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FDA 510(k)

ACCESS DHEA-S REAGENT ASSAY

K-Number: K040181 · 2004-03-24

ApplicantBeckman Coulter, Inc.
Decision Date2004-03-24
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS DHEA-S REAGENT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2004-03-24 under 510(k) number K040181. The device is classified under product code JKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS DHEA-S REAGENT ASSAY?

ACCESS DHEA-S REAGENT ASSAY is a medical device that received FDA 510(k) clearance on 2004-03-24. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K040181.

When did ACCESS DHEA-S REAGENT ASSAY receive FDA 510(k) clearance?

ACCESS DHEA-S REAGENT ASSAY received FDA 510(k) clearance on 2004-03-24, under 510(k) number K040181.

Who is the listed applicant for ACCESS DHEA-S REAGENT ASSAY?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCESS DHEA-S REAGENT ASSAY?

The FDA product code for ACCESS DHEA-S REAGENT ASSAY is JKC.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: JKC)

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.

K003174ELECSYS DHEA-SRoche Diagnostics Corp.K973897DHEA-SKmi Diagnostics, Inc.K962895DSL DHEA-S-7Diagnostic Systems Laboratories, Inc.K955114DSL AACTIVE DHEA EIA KITDiagnostic Systems Laboratories, Inc.K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYNichols InstituteK942051SR1 DHEA-S ENZYME IMMUNOASSAYSerono Diagnostics, 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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