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FDA 510(k)

125 I-DEHYDROEPIANDROSTERONE SULFATE

K-Number: K823200 · 1982-11-29

ApplicantWien Laboratories, Inc.
Decision Date1982-11-29
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125 I-DEHYDROEPIANDROSTERONE SULFATE 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 1982-11-29 under 510(k) number K823200. 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 125 I-DEHYDROEPIANDROSTERONE SULFATE?

125 I-DEHYDROEPIANDROSTERONE SULFATE is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K823200.

When did 125 I-DEHYDROEPIANDROSTERONE SULFATE receive FDA 510(k) clearance?

125 I-DEHYDROEPIANDROSTERONE SULFATE received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823200.

Who is the listed applicant for 125 I-DEHYDROEPIANDROSTERONE SULFATE?

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 125 I-DEHYDROEPIANDROSTERONE SULFATE?

The FDA product code for 125 I-DEHYDROEPIANDROSTERONE SULFATE 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 125IK821652DOXEPIN TRI-CY TEST SETK821653PROTRIPTYLINE TRI-CY TEST SETK802728125I-TESTOSTERONE 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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