Axsym Acetaminophen
FDA 510(k) K953094 · Abbott Laboratories
510(k) numberK953094
Submission
- Device name
- Axsym Acetaminophen
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 3, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K100200 | Advia Chemistry Acetaminophen Reagent, Model Ref 07989138LDP · Traditional | Siemens Healthcare Diagnostics | 08/02/2010SE |
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| 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 |
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Questions and answers
When was Axsym Acetaminophen cleared by the FDA?
Axsym Acetaminophen (K953094) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 52 days after the submission was received.
What is the product code of K953094?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.