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FDA 510(k)

DHEA-SULFATE I RIA KIT

K-Number: K832154 · 1983-08-16

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1983-08-16
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DHEA-SULFATE I RIA 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 1983-08-16 under 510(k) number K832154. 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-SULFATE I RIA KIT?

DHEA-SULFATE I RIA KIT is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K832154.

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

DHEA-SULFATE I RIA KIT received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832154.

Who is the listed applicant for DHEA-SULFATE I RIA 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 DHEA-SULFATE I RIA KIT?

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

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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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