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)

INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT

K-Number: K853484 · 1986-02-05

ApplicantBiotech Research Laboratories, Inc.
Decision Date1986-02-05
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Research Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-05 under 510(k) number K853484. The device is classified under product code GNP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT?

INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Biotech Research Laboratories, Inc.. The 510(k) number is K853484.

When did INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT receive FDA 510(k) clearance?

INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT received FDA 510(k) clearance on 1986-02-05, under 510(k) number K853484.

Who is the listed applicant for INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT?

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

What is the FDA product code for INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT?

The FDA product code for INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT is GNP.

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 Biotech Research 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.

K821849EBV-VCA ANTIBODY ASSAY KIT

Related Devices (Code: GNP)

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.

K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan Bio Pty. , Ltd.K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, 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.

↑