ACS Human Plasma Coagulation Control Level III
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K894425 FDA 510(k)
- FDA Product Code
- GGC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ACS Human Plasma Coagulation Control Level III is a control plasma device used for coagulation testing. It is classified as an abnormal plasma control and is designed to monitor the performance of coagulation testing systems.
This device is supplied as a quality control product and is intended for in-vitro diagnostic use. It is a Class II device with special controls, as cleared by the FDA under 510(k) number K894425. The device is manufactured by Analytical Control Systems, Inc. and is registered under registration number 1721937.
Frequently asked questions
What is the ACS Human Plasma Coagulation Control Level III used for?
This is an abnormal plasma control device designed to monitor the performance of coagulation testing systems. It serves as a quality control product for in-vitro diagnostic use, ensuring the accuracy and reliability of coagulation test results.
How is the ACS Human Plasma Coagulation Control Level III supplied?
The device is supplied as a quality control product specifically designed for in-vitro diagnostic use. It is manufactured by Analytical Control Systems, Inc. and is registered under registration number 1721937.
What is the regulatory classification of this device?
The ACS Human Plasma Coagulation Control Level III is classified as a Class II device with special controls. It has been cleared by the FDA under 510(k) number K894425, with a decision date of 1989-08-03, indicating it is substantially equivalent to predicate devices.
Is this device single-use or reusable?
The device description does not specify whether it is single-use or reusable. As a quality control product for coagulation testing, it is typically used in laboratory settings where usage protocols would determine if it can be reused or must be discarded after single use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acs Human Plasma Coagulation Control Level Iii, K894425 FDA 510(k) - ACS HUMAN PLASMA COAGULATION CONTROL LE..., PDF K894425 - Acs Human Plasma Coagulation Control Level Iii, Analytical Control Systems, Inc., ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III 510(k) K894425 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894425 | Class II | Active |
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Manufacturer
- Manufacturer
- Analytical Control Systems Inc
- FDA Applicant
- Analytical Control Systems, Inc.
Sources (1)
- FDA 510(k) K894425 24 fields · synced Sep 22, 2026