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FDA 510(k)

ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)

K-Number: K935014 · 1994-05-09

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1994-05-09
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1994-05-09 under 510(k) number K935014. 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 ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)?

ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) is a medical device that received FDA 510(k) clearance on 1994-05-09. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K935014.

When did ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) receive FDA 510(k) clearance?

ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) received FDA 510(k) clearance on 1994-05-09, under 510(k) number K935014.

Who is the listed applicant for ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)?

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

What is the FDA product code for ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)?

The FDA product code for ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) is JKC.

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Other records listing Diagnostic Systems Laboratories, Inc. 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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.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 Institute

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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