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)

AMPLIFIED ELISA IGE KIT

K-Number: K862368 · 1986-07-03

ApplicantAllertec, Inc.
Decision Date1986-07-03
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMPLIFIED ELISA IGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Allertec, Inc.. It received FDA 510(k) clearance on 1986-07-03 under 510(k) number K862368. 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 AMPLIFIED ELISA IGE KIT?

AMPLIFIED ELISA IGE KIT is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Allertec, Inc.. The 510(k) number is K862368.

When did AMPLIFIED ELISA IGE KIT receive FDA 510(k) clearance?

AMPLIFIED ELISA IGE KIT received FDA 510(k) clearance on 1986-07-03, under 510(k) number K862368.

Who is the listed applicant for AMPLIFIED ELISA IGE KIT?

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

What is the FDA product code for AMPLIFIED ELISA IGE KIT?

The FDA product code for AMPLIFIED ELISA IGE KIT 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

Other records listing Allertec, 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.

K863394RAPID SPECIFIC IGE PROCEDURE

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.

↑