De-Tox Tubes a and De-Tox Tubes B
FDA 510(k) K904326 · Dyna-Tek Industries
510(k) numberK904326
Submission
- Device name
- De-Tox Tubes a and De-Tox Tubes B
- Applicant
- Dyna-Tek Industries
Lenexa, KS, US - Received
- September 20, 1990
- Decision date
- January 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPA – Apparatus, General Use, Thin Layer Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2270
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884176 | Chromatography KitDPA · Traditional | Gelman Sciences, Inc. | 04/04/1989SE |
| K791431 | Technicon Fast-Lc Sys. for TheophyllineDPA · Traditional | Technicon Instruments Corp. | 10/11/1979SE |
| K770765 | Reagent Set, RenorpaceDPA · Traditional | G.D. Searle and Co. | 06/24/1977SE |
| K760908 | Miniature Ascending Paper Chromato-DPA · Traditional | Ackerman Nuclear, Inc. | 11/19/1976SE |
More from Ackerman Nuclear, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964771 | De-Tox Control 1 and De-Tox Control 19DIF · Traditional | 02/04/1997SE |
Questions and answers
When was De-Tox Tubes a and De-Tox Tubes B cleared by the FDA?
De-Tox Tubes a and De-Tox Tubes B (K904326) received a 510(k) decision of Substantially Equivalent on January 17, 1991, 119 days after the submission was received.
What is the product code of K904326?
The FDA product code is DPA – Apparatus, General Use, Thin Layer Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2270.