Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control
FDA 510(k) K080057 · Novx Systems, Inc.
510(k) numberK080057
Submission
- Device name
- Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control
- Applicant
- Novx Systems, Inc.
Rockville, MD, US - Received
- January 9, 2008
- Decision date
- October 31, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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|---|---|---|
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Questions and answers
When was Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control cleared by the FDA?
Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control (K080057) received a 510(k) decision of Substantially Equivalent on October 31, 2008, 296 days after the submission was received.
What is the product code of K080057?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.