Emit Serum Tricyclic Antidepress. Contro
FDA 510(k) K831979 · Syva Co.
510(k) numberK831979
Submission
- Device name
- Emit Serum Tricyclic Antidepress. Contro
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- June 20, 1983
- Decision date
- July 19, 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 Emit Serum Tricyclic Antidepress. Contro cleared by the FDA?
Emit Serum Tricyclic Antidepress. Contro (K831979) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 29 days after the submission was received.
What is the product code of K831979?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.