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FDA 510(k)

DSL DHEA-S-7

K-Number: K962895 · 1996-09-10

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1996-09-10
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL DHEA-S-7 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 1996-09-10 under 510(k) number K962895. 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 DHEA-S-7?

DSL DHEA-S-7 is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K962895.

When did DSL DHEA-S-7 receive FDA 510(k) clearance?

DSL DHEA-S-7 received FDA 510(k) clearance on 1996-09-10, under 510(k) number K962895.

Who is the listed applicant for DSL DHEA-S-7?

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 DHEA-S-7?

The FDA product code for DSL DHEA-S-7 is JKC.

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.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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