Doa Liquid Multi-Analyte Drugs of Abuse Controls
FDA 510(k) K904905 · Medical Analysis Systems, Inc.
510(k) numberK904905
Submission
- Device name
- Doa Liquid Multi-Analyte Drugs of Abuse Controls
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- October 30, 1990
- Decision date
- December 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Doa Liquid Multi-Analyte Drugs of Abuse Controls cleared by the FDA?
Doa Liquid Multi-Analyte Drugs of Abuse Controls (K904905) received a 510(k) decision of Substantially Equivalent on December 11, 1990, 42 days after the submission was received.
What is the product code of K904905?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.