Easy-Test Emit Acetaminophen (Actm) No. 16653
FDA 510(k) K882719 · Em Diagnostic Systems, Inc.
510(k) numberK882719
Submission
- Device name
- Easy-Test Emit Acetaminophen (Actm) No. 16653
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- July 1, 1988
- Decision date
- August 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDP – Colorimetry, Acetaminophen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3030
- Specialty
- Clinical Toxicology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/24/2026SE |
| K202644 | AcetaminophenLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/18/2022SE |
| K180835 | SEKURE Acetaminophen L3K AssayLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/08/2019SE |
| K110726 | Roche Acetaminophen AssayLDP · Traditional | Roche Diagnostics | 12/23/2011SE |
| K100200 | Advia Chemistry Acetaminophen Reagent, Model Ref 07989138LDP · Traditional | Siemens Healthcare Diagnostics | 08/02/2010SE |
| K081938 | Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30LDP · Traditional | Genzyme Diagnostics P.E.I., Inc. | 05/01/2009SE |
| K061655 | Dimension Vista Flex Reagent CartridgesLDP · Special | Dade Behring, Inc. | 07/10/2006SE |
| K043242 | Triage Tox Drug ScreenLDP · Traditional | Biosite Incorporated | 02/28/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | Diagnostic Chemicals , Ltd. | 01/07/2005SE |
| K020792 | Acetaminophen Assay for the Advia Integrated Modular SystemLDP · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
More from Bayer Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Easy-Test Emit Acetaminophen (Actm) No. 16653 cleared by the FDA?
Easy-Test Emit Acetaminophen (Actm) No. 16653 (K882719) received a 510(k) decision of Substantially Equivalent on August 8, 1988, 38 days after the submission was received.
What is the product code of K882719?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.