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Auratek Fdp

by Organon Teknika Corp.

510(k) K943787

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 NumberK943787 Date20 Sep 1994ClearedStatusActive

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  • Withdrawn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
DAP
Device Class
Class II
Regulation
21 CFR Part 864.7320
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Auratek Fdp is a fibrinogen and fibrin split products antigen, antiserum, control device, classified as a class 2 device. It is used in the field of hematology. The device is substantially equivalent to other devices on the market.

The Auratek Fdp is supplied with various registration numbers, including 3005174594, 2517506, and 1219738, and is regulated under regulation number 864.7320. It has been cleared by the FDA under the traditional clearance type, with a decision date of 1994-09-20 and k number K943787.

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Questions

AI-generated answers, 23 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 Auratek Fdp used for?

    The Auratek Fdp is used in the field of hematology as a fibrinogen and fibrin split products antigen, antiserum, control device.

  • Is the Auratek Fdp a single-use device?

    The device data does not specify whether the Auratek Fdp is single-use or reusable, but it is classified as a class 2 device.

  • What are the registration numbers for the Auratek Fdp?

    The Auratek Fdp has various registration numbers, including 3005174594, 2517506, and 1219738.

  • How is the Auratek Fdp regulated?

    The Auratek Fdp is regulated under regulation number 864.7320 and has been cleared by the FDA under the traditional clearance type.