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FDA 510(k)

CROATEST (R) RHEUMATOID DIAGNOSTIC

K-Number: K904416 · 1991-06-24

ApplicantBiotrax, Inc.
Decision Date1991-06-24
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CROATEST (R) RHEUMATOID DIAGNOSTIC is the device name listed in this FDA 510(k) record. The listed applicant is Biotrax, Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K904416. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROATEST (R) RHEUMATOID DIAGNOSTIC?

CROATEST (R) RHEUMATOID DIAGNOSTIC is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Biotrax, Inc.. The 510(k) number is K904416.

When did CROATEST (R) RHEUMATOID DIAGNOSTIC receive FDA 510(k) clearance?

CROATEST (R) RHEUMATOID DIAGNOSTIC received FDA 510(k) clearance on 1991-06-24, under 510(k) number K904416.

Who is the listed applicant for CROATEST (R) RHEUMATOID DIAGNOSTIC?

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

What is the FDA product code for CROATEST (R) RHEUMATOID DIAGNOSTIC?

The FDA product code for CROATEST (R) RHEUMATOID DIAGNOSTIC is GTQ.

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 Biotrax, 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.

K904496CROMATEST SYPHILIS DIAGNOSTICK904497CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TESTK904498CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST

Related Devices (Code: GTQ)

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.

K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;Ortho-Clinical DiagnosticsK953437OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K915742TURBIQUANT ASLBehring Diagnostics, Inc.K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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