Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANDROSTENEDIONE TEST SET 125I

K-Number: K832452 · 1983-09-12

ApplicantWien Laboratories, Inc.
Decision Date1983-09-12
Product CodeCIZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANDROSTENEDIONE TEST SET 125I 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 1983-09-12 under 510(k) number K832452. The device is classified under product code CIZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDROSTENEDIONE TEST SET 125I?

ANDROSTENEDIONE TEST SET 125I is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K832452.

When did ANDROSTENEDIONE TEST SET 125I receive FDA 510(k) clearance?

ANDROSTENEDIONE TEST SET 125I received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832452.

Who is the listed applicant for ANDROSTENEDIONE TEST SET 125I?

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 ANDROSTENEDIONE TEST SET 125I?

The FDA product code for ANDROSTENEDIONE TEST SET 125I is CIZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-OHK823200125 I-DEHYDROEPIANDROSTERONE SULFATEK821653PROTRIPTYLINE TRI-CY TEST SETK821652DOXEPIN TRI-CY TEST SETK802728125I-TESTOSTERONE TEST SET

View all 13 devices →

Related Devices (Code: CIZ)

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.

K963002ACTIVE ANDROSTENEDIONE EIADiagnostic Systems Laboratories, Inc.K954755COAT-A-COUNT DIRECT ANDROSTENEDIONEDiagnostic Products Corp.K934751ACTIVE ANDROSTANEDIOL GLUCURONIDEDiagnostic Systems Laboratories, Inc.K860559ANDROSTENEDIONE 125I KIT BY RIAImmuchem Corp.K854673DSL ANDROSTENEDIONE RIA (DSL # 4200)Diagnostic Systems Laboratories, Inc.K854650DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)Diagnostic Systems Laboratories, 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.

↑