Helena Factor Xii Deficient
FDA 510(k) K792656 · Helena Laboratories
510(k) numberK792656
Submission
- Device name
- Helena Factor Xii Deficient
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- December 26, 1979
- Decision date
- January 24, 1980
- 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 Helena Factor Xii Deficient cleared by the FDA?
Helena Factor Xii Deficient (K792656) received a 510(k) decision of Substantially Equivalent on January 24, 1980, 29 days after the submission was received.
What is the product code of K792656?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.