Immunoassay Drugs of Abuse Controls
FDA 510(k) K952056 · Medi-Tech, Inc.
510(k) numberK952056
Submission
- Device name
- Immunoassay Drugs of Abuse Controls
- Applicant
- Medi-Tech, Inc.
Ventura, CA, US - Received
- May 2, 1995
- Decision date
- June 1, 1995
- 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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| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
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| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
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Questions and answers
When was Immunoassay Drugs of Abuse Controls cleared by the FDA?
Immunoassay Drugs of Abuse Controls (K952056) received a 510(k) decision of Substantially Equivalent on June 1, 1995, 30 days after the submission was received.
What is the product code of K952056?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.