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)

AUTOGROUPER 16C SYS AUTOMATED REAG

K-Number: K834149 · 1984-03-09

ApplicantTechnicon Instruments Corp.
Decision Date1984-03-09
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AUTOGROUPER 16C SYS AUTOMATED REAG is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1984-03-09 under 510(k) number K834149. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOGROUPER 16C SYS AUTOMATED REAG?

AUTOGROUPER 16C SYS AUTOMATED REAG is a medical device that received FDA 510(k) clearance on 1984-03-09. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K834149.

When did AUTOGROUPER 16C SYS AUTOMATED REAG receive FDA 510(k) clearance?

AUTOGROUPER 16C SYS AUTOMATED REAG received FDA 510(k) clearance on 1984-03-09, under 510(k) number K834149.

Who is the listed applicant for AUTOGROUPER 16C SYS AUTOMATED REAG?

The FDA 510(k) record lists Technicon Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOGROUPER 16C SYS AUTOMATED REAG?

The FDA product code for AUTOGROUPER 16C SYS AUTOMATED REAG is GMQ.

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 Technicon Instruments Corp. 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

View all 157 devices →

Related Devices (Code: GMQ)

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.

K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLCK201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi)K182391ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi)K173376ASI EvolutionArlington Scientific, Inc. (Asi)K000687THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTBeacon Biologicals, Inc.K993633SYNTHETIC VDRL ANTIGENCenters for Disease Control and Prevention

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.

↑