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FDA 510(k)

DSL AACTIVE DHEA EIA KIT

K-Number: K955114 · 1996-02-23

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1996-02-23
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL AACTIVE DHEA EIA KIT 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 1996-02-23 under 510(k) number K955114. 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 DSL AACTIVE DHEA EIA KIT?

DSL AACTIVE DHEA EIA KIT is a medical device that received FDA 510(k) clearance on 1996-02-23. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K955114.

When did DSL AACTIVE DHEA EIA KIT receive FDA 510(k) clearance?

DSL AACTIVE DHEA EIA KIT received FDA 510(k) clearance on 1996-02-23, under 510(k) number K955114.

Who is the listed applicant for DSL AACTIVE DHEA EIA KIT?

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 DSL AACTIVE DHEA EIA KIT?

The FDA product code for DSL AACTIVE DHEA EIA KIT 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.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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