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)

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR

K-Number: K900010 · 1990-04-03

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1990-04-03
Product CodeJFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1990-04-03 under 510(k) number K900010. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR?

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR is a medical device that received FDA 510(k) clearance on 1990-04-03. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K900010.

When did NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR receive FDA 510(k) clearance?

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR received FDA 510(k) clearance on 1990-04-03, under 510(k) number K900010.

Who is the listed applicant for NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR?

The FDA product code for NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR is JFT.

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 Kallestad Diag, A Div. of Erbamont, 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.

K910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKK910887QM300 CONTROL G PACKK910885QM300 CALIBRATOR G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TEST

View all 58 devices →

Related Devices (Code: JFT)

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.

K242505Elecsys Cortisol IIIRoche DiagnosticsK192788ADVIA Centaur Cortisol (COR)Siemens Healthcare Diagnostics, Inc.K152227Elecsys Cortisol II, Cortisol II CalSetRoche DiagnosticsK062204ARCHITECT CORTISOL ASSAYSeradyn, Inc.K033731AXSYM CORTISOL ASSAYFujirebio Diagnostics,Inc.K021218ELECSYS CORTISOL TEST SYSTEMRoche Diagnostics Corp.

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.

↑