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FDA 510(k)

I-DHEA-SULFATE RIA KIT 125

K-Number: K821145 · 1982-05-14

ApplicantNuclear Medical Systems, Inc.
Decision Date1982-05-14
Product CodeJKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-DHEA-SULFATE RIA KIT 125 is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K821145. 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 I-DHEA-SULFATE RIA KIT 125?

I-DHEA-SULFATE RIA KIT 125 is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Nuclear Medical Systems, Inc.. The 510(k) number is K821145.

When did I-DHEA-SULFATE RIA KIT 125 receive FDA 510(k) clearance?

I-DHEA-SULFATE RIA KIT 125 received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821145.

Who is the listed applicant for I-DHEA-SULFATE RIA KIT 125?

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

What is the FDA product code for I-DHEA-SULFATE RIA KIT 125?

The FDA product code for I-DHEA-SULFATE RIA KIT 125 is JKC.

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 Nuclear Medical Systems, 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.

K791582CARDIO CK-B RIA KITK791735PAP RIA KITK780679B-HCG-RIAK771378NEO TSH-RIA KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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