Profile II Er
FDA 510(k) K010138 · Medtox Diagnostics, Inc.
510(k) numberK010138
Submission
- Device name
- Profile II Er
- Applicant
- Medtox Diagnostics, Inc.
Burlington, NC, US - Received
- January 17, 2001
- Decision date
- February 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K033334 | Profile -ErDIS · Special | 11/10/2003SE |
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Questions and answers
When was Profile II Er cleared by the FDA?
Profile II Er (K010138) received a 510(k) decision of Substantially Equivalent on February 14, 2001, 28 days after the submission was received.
What is the product code of K010138?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.