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Koagulab 40-A Automated Coagulation Sys

by Ortho Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K823131

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823131 Date9 Dec 1982ClearedStatusActive

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  • Withdrawn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
KQG
Device Class
Class II
Regulation
21 CFR Part 864.5400
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Koagulab 40-A Automated Coagulation System is an instrument for coagulation testing, classified as a hematology device under FDA product code KQG. It is a substantially equivalent device cleared via traditional 510(k) pathway. The system is designed for automated coagulation analysis in laboratory settings.

It is supplied as a reusable instrument intended for use in clinical laboratories. The device received FDA 510(k) clearance (K823131) on December 9, 1982, and is manufactured by Ortho Diagnostic Systems, Inc. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Koagulab 40-A Automated Coagulation System used for?

    The Koagulab 40-A is an instrument designed for automated coagulation analysis in laboratory settings, specifically for coagulation testing as a hematology device under FDA product code KQG.

  • Is the Koagulab 40-A supplied as a reusable or single-use device?

    The Koagulab 40-A is supplied as a reusable instrument intended for use in clinical laboratories, as stated in the device description.

  • What regulatory pathway was used for the Koagulab 40-A's FDA clearance?

    The Koagulab 40-A received FDA 510(k) clearance via the traditional pathway, as indicated by the clearance_type field and the K823131 number.