Mem D-Val Modif. M7395, W/Ebss, L-Glutamine, D-Val
FDA 510(k) K850922 · Sigma Chemical Co.
510(k) numberK850922
Submission
- Device name
- Mem D-Val Modif. M7395, W/Ebss, L-Glutamine, D-Val
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- March 5, 1985
- Decision date
- March 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIT – Media And Components, Synthetic Cell And Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2220
- Specialty
- Hematology
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Questions and answers
When was Mem D-Val Modif. M7395, W/Ebss, L-Glutamine, D-Val cleared by the FDA?
Mem D-Val Modif. M7395, W/Ebss, L-Glutamine, D-Val (K850922) received a 510(k) decision of Substantially Equivalent on March 25, 1985, 20 days after the submission was received.
What is the product code of K850922?
The FDA product code is KIT – Media And Components, Synthetic Cell And Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2220.