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)

ATAC PAK ALBUMIN REAGENT

K-Number: K030006 · 2003-03-07

ApplicantElan Diagnostics
Decision Date2003-03-07
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK ALBUMIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2003-03-07 under 510(k) number K030006. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK ALBUMIN REAGENT?

ATAC PAK ALBUMIN REAGENT is a medical device that received FDA 510(k) clearance on 2003-03-07. The listed applicant is Elan Diagnostics. The 510(k) number is K030006.

When did ATAC PAK ALBUMIN REAGENT receive FDA 510(k) clearance?

ATAC PAK ALBUMIN REAGENT received FDA 510(k) clearance on 2003-03-07, under 510(k) number K030006.

Who is the listed applicant for ATAC PAK ALBUMIN REAGENT?

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

What is the FDA product code for ATAC PAK ALBUMIN REAGENT?

The FDA product code for ATAC PAK ALBUMIN REAGENT is CIX.

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 Elan Diagnostics 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030015ATAC PAK PHOSPHORUS REAGENT

View all 13 devices →

Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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.

↑