Doa-Plus, Drugs of Abuse Controls
FDA 510(k) K942257 · Medical Diagnostic Technologies, Inc.
510(k) numberK942257
Submission
- Device name
- Doa-Plus, Drugs of Abuse Controls
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- May 9, 1994
- Decision date
- September 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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-Plus, Drugs of Abuse Controls cleared by the FDA?
Doa-Plus, Drugs of Abuse Controls (K942257) received a 510(k) decision of Substantially Equivalent on September 14, 1994, 128 days after the submission was received.
What is the product code of K942257?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.