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FDA 510(k)

DHEA-S RIA KIT

K-Number: K872879 · 1987-10-23

ApplicantEndocrine Associates, Inc.
Decision Date1987-10-23
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DHEA-S RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Endocrine Associates, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K872879. 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 DHEA-S RIA KIT?

DHEA-S RIA KIT is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is Endocrine Associates, Inc.. The 510(k) number is K872879.

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

DHEA-S RIA KIT received FDA 510(k) clearance on 1987-10-23, under 510(k) number K872879.

Who is the listed applicant for DHEA-S RIA KIT?

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

What is the FDA product code for DHEA-S RIA KIT?

The FDA product code for DHEA-S RIA KIT is JKC.

Other records listing Endocrine Associates, 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.

K872880CALCITONIN RIA KIT

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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