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FDA 510(k)

ELECSYS DHEA-S

K-Number: K003174 · 2001-01-17

ApplicantRoche Diagnostics Corp.
Decision Date2001-01-17
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS DHEA-S is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-01-17 under 510(k) number K003174. 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 ELECSYS DHEA-S?

ELECSYS DHEA-S is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K003174.

When did ELECSYS DHEA-S receive FDA 510(k) clearance?

ELECSYS DHEA-S received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003174.

Who is the listed applicant for ELECSYS DHEA-S?

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

What is the FDA product code for ELECSYS DHEA-S?

The FDA product code for ELECSYS DHEA-S is JKC.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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.

K040181ACCESS DHEA-S REAGENT ASSAYBeckman Coulter, Inc.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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