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FDA 510(k)

CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST

K-Number: K904497 · 1990-11-01

ApplicantBiotrax, Inc.
Decision Date1990-11-01
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biotrax, Inc.. It received FDA 510(k) clearance on 1990-11-01 under 510(k) number K904497. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST?

CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST is a medical device that received FDA 510(k) clearance on 1990-11-01. The listed applicant is Biotrax, Inc.. The 510(k) number is K904497.

When did CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST receive FDA 510(k) clearance?

CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST received FDA 510(k) clearance on 1990-11-01, under 510(k) number K904497.

Who is the listed applicant for CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST?

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 CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST?

The FDA product code for CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST is DCN.

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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 DIAGNOSTICK904416CROATEST (R) RHEUMATOID DIAGNOSTICK904498CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST

Related Devices (Code: DCN)

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.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

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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