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)

RPR CARD TEST SYSTEM

K-Number: K810658 · 1981-03-31

ApplicantBeckman Instruments, Inc.
Decision Date1981-03-31
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RPR CARD TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810658. 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 RPR CARD TEST SYSTEM?

RPR CARD TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K810658.

When did RPR CARD TEST SYSTEM receive FDA 510(k) clearance?

RPR CARD TEST SYSTEM received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810658.

Who is the listed applicant for RPR CARD TEST SYSTEM?

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

What is the FDA product code for RPR CARD TEST SYSTEM?

The FDA product code for RPR CARD TEST SYSTEM 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 Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

View all 281 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.

↑