Technicon Fast-Lc Sys. for Theophylline
FDA 510(k) K791431 · Technicon Instruments Corp.
510(k) numberK791431
Submission
- Device name
- Technicon Fast-Lc Sys. for Theophylline
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- July 26, 1979
- Decision date
- October 11, 1979
- 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 |
|---|---|---|---|
| K904326 | De-Tox Tubes a and De-Tox Tubes BDPA · Traditional | Dyna-Tek Industries | 01/17/1991SE |
| K884176 | Chromatography KitDPA · Traditional | Gelman Sciences, Inc. | 04/04/1989SE |
| 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 |
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| 510(k) | Device | Decision |
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| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
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| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon Fast-Lc Sys. for Theophylline cleared by the FDA?
Technicon Fast-Lc Sys. for Theophylline (K791431) received a 510(k) decision of Substantially Equivalent on October 11, 1979, 77 days after the submission was received.
What is the product code of K791431?
The FDA product code is DPA – Apparatus, General Use, Thin Layer Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2270.