De-Tox Control 1 and De-Tox Control 19
FDA 510(k) K964771 · Dyna-Tek Industries
510(k) numberK964771
Submission
- Device name
- De-Tox Control 1 and De-Tox Control 19
- Applicant
- Dyna-Tek Industries
Lenexa, KS, US - Received
- November 27, 1996
- Decision date
- February 4, 1997
- 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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| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K904326 | De-Tox Tubes a and De-Tox Tubes BDPA · Traditional | 01/17/1991SE |
Questions and answers
When was De-Tox Control 1 and De-Tox Control 19 cleared by the FDA?
De-Tox Control 1 and De-Tox Control 19 (K964771) received a 510(k) decision of Substantially Equivalent on February 4, 1997, 69 days after the submission was received.
What is the product code of K964771?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.