Technicon Fast-Lc Sys. Anticonvu Drugs
FDA 510(k) K791979 · Technicon Instruments Corp.
510(k) numberK791979
Submission
- Device name
- Technicon Fast-Lc Sys. Anticonvu Drugs
- Applicant
- Technicon Instruments Corp.
Walker, MI, US - Received
- September 25, 1979
- Decision date
- November 13, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPE – Thin Layer Chromatography, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
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Questions and answers
When was Technicon Fast-Lc Sys. Anticonvu Drugs cleared by the FDA?
Technicon Fast-Lc Sys. Anticonvu Drugs (K791979) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 49 days after the submission was received.
What is the product code of K791979?
The FDA product code is DPE – Thin Layer Chromatography, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.