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Orthokrome Factor VIII

by Ortho Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K900395

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900395 Date15 Mar 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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GGP
Device Class
Class II
Regulation
21 CFR Part 864.7290
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Orthokrome Factor VIII is a test for qualitative and quantitative factor deficiency. It is a hematology device used to assess Factor VIII levels.

The device is supplied by Ortho Diagnostic Systems, Inc. and has FDA 510(k) clearance under product code GGP and regulation number 864.7290. It was cleared on March 15, 1990, under K900395.

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