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)

CHAGAS' IGG ELISA TEST

K-Number: K911233 · 1992-05-04

ApplicantGull Laboratories, Inc.
Decision Date1992-05-04
Product CodeMIU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHAGAS' IGG ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1992-05-04 under 510(k) number K911233. The device is classified under product code MIU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHAGAS' IGG ELISA TEST?

CHAGAS' IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1992-05-04. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K911233.

When did CHAGAS' IGG ELISA TEST receive FDA 510(k) clearance?

CHAGAS' IGG ELISA TEST received FDA 510(k) clearance on 1992-05-04, under 510(k) number K911233.

Who is the listed applicant for CHAGAS' IGG ELISA TEST?

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

What is the FDA product code for CHAGAS' IGG ELISA TEST?

The FDA product code for CHAGAS' IGG ELISA TEST is MIU.

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 Gull Laboratories, 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.

K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

View all 57 devices →

Related Devices (Code: MIU)

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.

K161947Chagas Detect Plus Rapid TestInBios International, Inc.K072732ORTHO T. CRUZI ELISA TEST SYSTEMOrtho-Clinical Diagnostics, Inc.K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254Wiener Laboratories SaicK930272HEMAGEN CHAGAS' KIT (EIA METHOD)Hemagen Diagnostics, Inc.K933716ABBOTT CHAGAS ANTIBODY EIAAbbott Laboratories

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.

↑