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)

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

K-Number: K970227 · 1997-04-08

ApplicantDpc Cirrus
Decision Date1997-04-08
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Dpc Cirrus. It received FDA 510(k) clearance on 1997-04-08 under 510(k) number K970227. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER?

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 1997-04-08. The listed applicant is Dpc Cirrus. The 510(k) number is K970227.

When did IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 1997-04-08, under 510(k) number K970227.

Who is the listed applicant for IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER?

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

What is the FDA product code for IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER?

The FDA product code for IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER is JJE.

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 Dpc Cirrus 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.

K980855IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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.

↑