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Cromatest Rheumatoid Diagnostic/Rf Latex Test

by Biotrax, Inc. 510(k)

Active United States

510(k) K904498

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904498 Date29 Oct 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DHR
Device Class
Class II
Regulation
21 CFR Part 866.5775
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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