Coagulation Factor Viii Deficient Substrate Plasma
FDA 510(k) K853462 · American Dade
510(k) numberK853462
Submission
- Device name
- Coagulation Factor Viii Deficient Substrate Plasma
- Applicant
- American Dade
Santa Ana, CA, US - Received
- August 19, 1985
- Decision date
- August 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Coagulation Factor Viii Deficient Substrate Plasma cleared by the FDA?
Coagulation Factor Viii Deficient Substrate Plasma (K853462) received a 510(k) decision of Substantially Equivalent on August 29, 1985, 10 days after the submission was received.
What is the product code of K853462?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.