Acetaminophen-Sl Assay
FDA 510(k) K042330 · Diagnostic Chemicals , Ltd.
510(k) numberK042330
Submission
- Device name
- Acetaminophen-Sl Assay
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, Prince Edward, CA - Received
- August 27, 2004
- Decision date
- January 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K202644 | AcetaminophenLDP · Traditional | Sekisui Diagnostics P.E.I., Inc. | 02/18/2022SE |
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| K043242 | Triage Tox Drug ScreenLDP · Traditional | Biosite Incorporated | 02/28/2005SE |
| K020792 | Acetaminophen Assay for the Advia Integrated Modular SystemLDP · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
| K013757 | Roche AcetaminophenLDP · Traditional | Roche Diagnostics Corp. | 01/08/2002SE |
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| K042329 | Salicylate-Sl AssayDKJ · Traditional | 12/27/2004SE |
| K041928 | Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50BLBS · Traditional | 11/23/2004SE |
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Questions and answers
When was Acetaminophen-Sl Assay cleared by the FDA?
Acetaminophen-Sl Assay (K042330) received a 510(k) decision of Substantially Equivalent on January 7, 2005, 133 days after the submission was received.
What is the product code of K042330?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.