Advance Emit-Cad Disopyramide Control
FDA 510(k) K830049 · Syva Co.
510(k) numberK830049
Submission
- Device name
- Advance Emit-Cad Disopyramide Control
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- January 10, 1983
- Decision date
- January 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Advance Emit-Cad Disopyramide Control cleared by the FDA?
Advance Emit-Cad Disopyramide Control (K830049) received a 510(k) decision of Substantially Equivalent on January 28, 1983, 18 days after the submission was received.
What is the product code of K830049?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.