Cromatest Rheumatoid Diagnostic/Crp Latex Test

FDA 510(k) K904497 · Biotrax, Inc.

Substantially Equivalent

510(k) numberK904497

Submission

Device name
Cromatest Rheumatoid Diagnostic/Crp Latex Test
Applicant
Biotrax, Inc.
Baltimore, MD, US
Received
October 2, 1990
Decision date
November 1, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DCN – System, Test, C-Reactive Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5270
Specialty
Immunology

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More from Roche Diagnostics Corp.

510(k)DeviceDecision
K904496Cromatest Syphilis DiagnosticGMQ · Traditional 07/24/1991SE
K904416Croatest (R) Rheumatoid DiagnosticGTQ · Traditional 06/24/1991SE
K904498Cromatest Rheumatoid Diagnostic/Rf Latex TestDHR · Traditional 10/29/1990SE

Questions and answers

When was Cromatest Rheumatoid Diagnostic/Crp Latex Test cleared by the FDA?

Cromatest Rheumatoid Diagnostic/Crp Latex Test (K904497) received a 510(k) decision of Substantially Equivalent on November 1, 1990, 30 days after the submission was received.

What is the product code of K904497?

The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.