Acetaminopher Assay Kit
FDA 510(k) K832045 · Quantimetrix Corp.
510(k) numberK832045
Submission
- Device name
- Acetaminopher Assay Kit
- Applicant
- Quantimetrix Corp.
Mchenry, IL, US - Received
- June 24, 1983
- Decision date
- October 4, 1983
- 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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Questions and answers
When was Acetaminopher Assay Kit cleared by the FDA?
Acetaminopher Assay Kit (K832045) received a 510(k) decision of Substantially Equivalent on October 4, 1983, 102 days after the submission was received.
What is the product code of K832045?
The FDA product code is LDP – Colorimetry, Acetaminophen, a Class II (moderate risk) device regulated under 21 CFR 862.3030.