Identifiers
- 510(k) Number
- K913250 FDA 510(k)
- FDA Product Code
- GJS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7750 FDA 510(k)
- Regulation Number
- 864.7750 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ACS Ultra-2 Thromboplastin is a test, time, prothrombin reagent used in hematology for in-vitro diagnostic testing. It is classified as a Class II medical device under regulation number 864.7750 and product code GJS.
The device is supplied by Analytical Control Systems, Inc. and received FDA 510(k) clearance (K913250) on November 27, 1991, following a traditional review process. It is intended for use in laboratory settings as part of prothrombin time testing procedures.
Frequently asked questions
What is the ACS Ultra-2 Thromboplastin used for?
ACS Ultra-2 Thromboplastin is a test, time, prothrombin reagent used in hematology for in-vitro diagnostic testing, specifically as part of prothrombin time testing procedures in laboratory settings.
How is the ACS Ultra-2 Thromboplastin supplied and what is its regulatory classification?
The device is supplied by Analytical Control Systems, Inc. and is classified as a Class II medical device under regulation number 864.7750 and product code GJS, with FDA 510(k) clearance (K913250) obtained via a traditional review process on November 27, 1991.
Is the ACS Ultra-2 Thromboplastin intended for single-use or reuse in laboratory testing?
The device data does not specify whether the ACS Ultra-2 Thromboplastin is intended for single-use or reuse; it is described as a reagent for in-vitro diagnostic testing in laboratory settings, but no details on usage limitations or reusability are provided in the authorization or specifications.
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: PDF K913250 - Acs Ultra-2 Thromboplastin, ACS ULTRA-2 THROMBOPLASTIN 510 (k) K913250 - FDA.report, Analytical Control Systems, Inc., ACS Online Catalog
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K913250 | Class II | Active |
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Manufacturer
- Manufacturer
- Analytical Control Systems Inc
- FDA Applicant
- Analytical Control Systems, Inc.
Sources (1)
- FDA 510(k) K913250 24 fields · synced Sep 28, 2026