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)

IMMUNODIFFUSION REAGENTS/SEROLOGICAL

K-Number: K802129 · 1980-09-26

ApplicantNolan Biological Laboratories, Inc.
Decision Date1980-09-26
Product CodeGMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNODIFFUSION REAGENTS/SEROLOGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Nolan Biological Laboratories, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802129. The device is classified under product code GMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNODIFFUSION REAGENTS/SEROLOGICAL?

IMMUNODIFFUSION REAGENTS/SEROLOGICAL is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Nolan Biological Laboratories, Inc.. The 510(k) number is K802129.

When did IMMUNODIFFUSION REAGENTS/SEROLOGICAL receive FDA 510(k) clearance?

IMMUNODIFFUSION REAGENTS/SEROLOGICAL received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802129.

Who is the listed applicant for IMMUNODIFFUSION REAGENTS/SEROLOGICAL?

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

What is the FDA product code for IMMUNODIFFUSION REAGENTS/SEROLOGICAL?

The FDA product code for IMMUNODIFFUSION REAGENTS/SEROLOGICAL is GMI.

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 Nolan Biological 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.

K812741REAGENTS FOR SERODIAGNOSIS OF CANDIDOSISK812740REAGENTS FOR SERODIAGNOSIS OF ASPERGILLK802130IMMUNO. IDENTIFICATION OF H. CAPSULATUMK802128IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

Related Devices (Code: GMI)

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.

K894617OLYMPUS PK-TP SYSTEM REACTIVE CONTROLSchiff & Co.K812190COCCIDIOIDES IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK812185FUNGAL IMMUNODIFFUSION SYSTEMAmerican Scientific ProductsK792716CANDIDA ALBICANS, ANTIGENMeridian Diagnostics, Inc.K792713CANDIDA ALBICANS, ANTISERUMMeridian Diagnostics, Inc.K792682COCCIDIOIDES IMMITIS, ANTIGENMeridian Diagnostics, 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.

↑