Lancer Coagent Human Factor 1X Plasma
FDA 510(k) K812974 · Sherwood Medical Co.
510(k) numberK812974
Submission
- Device name
- Lancer Coagent Human Factor 1X Plasma
- Applicant
- Sherwood Medical Co.
Mchenry, IL, US - Received
- October 23, 1981
- Decision date
- November 16, 1981
- 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 Lancer Coagent Human Factor 1X Plasma cleared by the FDA?
Lancer Coagent Human Factor 1X Plasma (K812974) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 24 days after the submission was received.
What is the product code of K812974?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.