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FDA 510(k)

DSL ACTIVE ALDOSTERONE (DSL 8600)

K-Number: K921205 · 1992-07-10

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1992-07-10
Product CodeCJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL ACTIVE ALDOSTERONE (DSL 8600) 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 1992-07-10 under 510(k) number K921205. The device is classified under product code CJM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL ACTIVE ALDOSTERONE (DSL 8600)?

DSL ACTIVE ALDOSTERONE (DSL 8600) is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K921205.

When did DSL ACTIVE ALDOSTERONE (DSL 8600) receive FDA 510(k) clearance?

DSL ACTIVE ALDOSTERONE (DSL 8600) received FDA 510(k) clearance on 1992-07-10, under 510(k) number K921205.

Who is the listed applicant for DSL ACTIVE ALDOSTERONE (DSL 8600)?

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 DSL ACTIVE ALDOSTERONE (DSL 8600)?

The FDA product code for DSL ACTIVE ALDOSTERONE (DSL 8600) is CJM.

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 Diagnostic Systems 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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Related Devices (Code: CJM)

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.

K130321LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERSDiasorinK050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute DiagnosticsK032188NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute DiagnosticsK943397DSL ACTIVE ALDOSTERONE RIA (DSL 8600)Diagnostic Systems Laboratories, Inc.K862204RSL (125I) ALDOSTERONE KITRadioassay Systems Laboratories, Inc.K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITSerono 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.

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