Acetaminophen Stat-Pak Reagent Set

FDA 510(k) K821969 · Clin Tech Diagnostics Corp.

Substantially Equivalent

510(k) numberK821969

Submission

Device name
Acetaminophen Stat-Pak Reagent Set
Applicant
Clin Tech Diagnostics Corp.
Mchenry, IL, US
Received
July 1, 1982
Decision date
July 16, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
K820076Glyco-Sep Reagent Test SetLCP · Traditional 02/12/1982SE
K813185Salicylate Stat-PakDKJ · Traditional 11/24/1981SE
K810235Acetaminophen/Salicylate ControlDIF · Traditional 02/10/1981SE
K802432Glyco-Trol Human Glycosylated Hom. Cont.LCP · Traditional 12/01/1980SE

Questions and answers

When was Acetaminophen Stat-Pak Reagent Set cleared by the FDA?

Acetaminophen Stat-Pak Reagent Set (K821969) received a 510(k) decision of Substantially Equivalent on July 16, 1982, 15 days after the submission was received.

What is the product code of K821969?

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