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Kd Activated Partial Thromboplastin Time Reagent

by King Diagnostics, Inc.

510(k) K884485

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884485 Date28 Dec 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GFO
Device Class
Class II
Regulation
21 CFR Part 864.7925
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.

This device is an activated partial thromboplastin time reagent used for primary screening for coagulation abnormalities, evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway. It is a laboratory reagent used in coagulation studies to determine how quickly a patient's blood clots.

The reagent is supplied for in vitro diagnostic use in clinical laboratory settings. It is classified as a Class II medical device under FDA regulation number 864.7925 and product code GFO, with FDA 510(k) clearance K884485 granted on December 28, 1988.

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