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)

NML CORTISOL RIA

K-Number: K840466 · 1984-03-30

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1984-03-30
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NML CORTISOL RIA is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840466. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NML CORTISOL RIA?

NML CORTISOL RIA is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K840466.

When did NML CORTISOL RIA receive FDA 510(k) clearance?

NML CORTISOL RIA received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840466.

Who is the listed applicant for NML CORTISOL RIA?

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

What is the FDA product code for NML CORTISOL RIA?

The FDA product code for NML CORTISOL RIA is CGR.

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 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.

K852438NML TSH IRMAK844583TSH-STATK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEMK823679NML 6000 CT

View all 24 devices →

Related Devices (Code: CGR)

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.

K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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.

↑