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FDA 510(k)

DHEA-SULFATE TEST SET

K-Number: K792041 · 1979-10-30

ApplicantWien Laboratories, Inc.
Decision Date1979-10-30
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DHEA-SULFATE TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Wien Laboratories, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K792041. 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 TEST SET?

DHEA-SULFATE TEST SET is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K792041.

When did DHEA-SULFATE TEST SET receive FDA 510(k) clearance?

DHEA-SULFATE TEST SET received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792041.

Who is the listed applicant for DHEA-SULFATE TEST SET?

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

What is the FDA product code for DHEA-SULFATE TEST SET?

The FDA product code for DHEA-SULFATE TEST SET is JKC.

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Other records listing Wien 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.

K912850SHBGK834246PROGESTERONE TEST SET 125I 17-OHK832452ANDROSTENEDIONE TEST SET 125IK823200125 I-DEHYDROEPIANDROSTERONE SULFATEK821652DOXEPIN TRI-CY TEST SETK821653PROTRIPTYLINE TRI-CY TEST SET

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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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