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)

IMAGE-IGE

K-Number: K853025 · 1985-08-22

ApplicantClinical Reference Laboratory, Inc.
Decision Date1985-08-22
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMAGE-IGE is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Reference Laboratory, Inc.. It received FDA 510(k) clearance on 1985-08-22 under 510(k) number K853025. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE-IGE?

IMAGE-IGE is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Clinical Reference Laboratory, Inc.. The 510(k) number is K853025.

When did IMAGE-IGE receive FDA 510(k) clearance?

IMAGE-IGE received FDA 510(k) clearance on 1985-08-22, under 510(k) number K853025.

Who is the listed applicant for IMAGE-IGE?

The FDA 510(k) record lists Clinical Reference Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGE-IGE?

The FDA product code for IMAGE-IGE is DGC.

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

Related Devices (Code: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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.

↑