CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST— 510(k) K904498

Name: FDA 510(k) clearance K904498
Creator: U.S. Food and Drug Administration
Published: 1990-10-29

Substantially Equivalent

Biotrax, Inc.

FDA 510(k) clearance K904498 for CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST, Substantially Equivalent on 1990-10-29. Applicant: Biotrax, Inc.. Device class: 2.

Clearance details

Applicant: Biotrax, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1990-10-02
Decision date: 1990-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biotrax, Inc.

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K904496 — CROMATEST SYPHILIS DIAGNOSTIC1991-07-24
K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC1991-06-24
K904497 — CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST1990-11-01

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