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Cascade Liquid Coagulation Control Levels 1, 2, and 3

by Medical Analysis Systems, Inc. 510(k)

Active United States

510(k) K992829

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992829 Date22 Nov 1999ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GGN
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Cascade Liquid Coagulation Control Levels 1, 2, and 3 is a human plasma-based quality control material. It serves as a tool of known concentration for monitoring the performance of coagulation assays, including prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

This device is intended for use in the clinical laboratory setting. It has received FDA 510(k) clearance under the regulation number 864.5425.

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