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)

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

K-Number: K002638 · 2001-01-17

ApplicantFuture Diagnostics B.V.
Decision Date2001-01-17
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Future Diagnostics B.V.. It received FDA 510(k) clearance on 2001-01-17 under 510(k) number K002638. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT?

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Future Diagnostics B.V.. The 510(k) number is K002638.

When did FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT receive FDA 510(k) clearance?

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT received FDA 510(k) clearance on 2001-01-17, under 510(k) number K002638.

Who is the listed applicant for FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT?

The FDA 510(k) record lists Future Diagnostics B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT?

The FDA product code for FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT is CKG.

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 Future Diagnostics B.V. 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.

K000471FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

Related Devices (Code: CKG)

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.

K223867IDS ACTH IIImmunodiagnostic Systems LimitedK111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.K060585ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITSangui Biotech, 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.

↑