Skip to content

Coamatic Factor VIII

by Pharmacia Hepar, Inc.

510(k) K943225

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943225 Date6 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 25 Sep 2026

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

COAMATIC FACTOR VIII is a qualitative and quantitative test for factor deficiency, classified as a device in the Hematology specialty. It is intended for the determination of factor VIII activity in plasma, such as for identifying factor VIII deficiency or monitoring patients on replacement therapy.

The device is supplied as a chromogenic assay kit for photometric determination. It is regulated under FDA 510(k) clearance (K943225) and is not indicated for specific clinical indications beyond its stated purpose.

Other devices from Pharmacia Hepar, Inc.

Questions

AI-generated answers, 25 Sep 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 COAMATIC Factor VIII test used for?

    This device is a qualitative and quantitative test intended to determine factor VIII activity in plasma. It is used to identify factor VIII deficiency or to monitor patients undergoing replacement therapy.

  • How is the COAMATIC Factor VIII test supplied?

    The device is supplied as a chromogenic assay kit designed for photometric determination of factor VIII activity.

  • Is the COAMATIC Factor VIII test intended for single use?

    The device data does not specify whether it is intended for single use or reuse. Please refer to the manufacturer's instructions for use for specific guidance on the intended use and handling of the kit.

  • What is the regulatory status of the COAMATIC Factor VIII test?

    The COAMATIC Factor VIII is regulated under FDA 510(k) clearance (K943225). The device data indicates it is classified as a device in the Hematology specialty.