Acetasite

FDA 510(k) K931257 · Gds Diagnostics

Substantially Equivalent

510(k) numberK931257

Submission

Device name
Acetasite
Applicant
Gds Diagnostics
Elkhart, IN, US
Received
March 12, 1993
Decision date
July 8, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LDP – Colorimetry, Acetaminophen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3030
Specialty
Clinical Toxicology

Other 510(k)s with product code LDP

510(k)DeviceApplicantDecision
K261364Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional Siemens Healthcare Diagnostics, Inc.07/24/2026SE
K202644AcetaminophenLDP · Traditional Sekisui Diagnostics P.E.I., Inc.02/18/2022SE
K180835SEKURE Acetaminophen L3K AssayLDP · Traditional Sekisui Diagnostics P.E.I., Inc.02/08/2019SE
K110726Roche Acetaminophen AssayLDP · Traditional Roche Diagnostics12/23/2011SE
K100200Advia Chemistry Acetaminophen Reagent, Model Ref 07989138LDP · Traditional Siemens Healthcare Diagnostics08/02/2010SE
K081938Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30LDP · Traditional Genzyme Diagnostics P.E.I., Inc.05/01/2009SE
K061655Dimension Vista Flex Reagent CartridgesLDP · Special Dade Behring, Inc.07/10/2006SE
K043242Triage Tox Drug ScreenLDP · Traditional Biosite Incorporated02/28/2005SE
K042330Acetaminophen-Sl AssayLDP · Traditional Diagnostic Chemicals , Ltd.01/07/2005SE
K020792Acetaminophen Assay for the Advia Integrated Modular SystemLDP · Traditional Bayer Diagnostics Corp.07/11/2002SE

More from Bayer Diagnostics Corp.

510(k)DeviceDecision
K910881Control and LinearityDKB · Traditional 09/13/1991SE
K910108GDS Enzymatic B-Hydroxybutyrate Reagent ModifiedJIN · Traditional 03/04/1991SE
K891761GDS Enzymatic Theophylline ReagentLCY · Traditional 05/16/1989SE

Questions and answers

When was Acetasite cleared by the FDA?

Acetasite (K931257) received a 510(k) decision of Substantially Equivalent on July 8, 1993, 118 days after the submission was received.

What is the product code of K931257?

The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.