Factor Xi Deficient Plasma B11D
FDA 510(k) K843438 · Sigma Chemical Co.
510(k) numberK843438
Submission
- Device name
- Factor Xi Deficient Plasma B11D
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- September 4, 1984
- Decision date
- November 19, 1984
- 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 Factor Xi Deficient Plasma B11D cleared by the FDA?
Factor Xi Deficient Plasma B11D (K843438) received a 510(k) decision of Substantially Equivalent on November 19, 1984, 76 days after the submission was received.
What is the product code of K843438?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.