Diacrom * Factor X Kit HA31
FDA 510(k) K832372 · Wellcome Diagnostics
510(k) numberK832372
Submission
- Device name
- Diacrom * Factor X Kit HA31
- Applicant
- Wellcome Diagnostics
Mchenry, IL, US - Received
- July 18, 1983
- Decision date
- September 29, 1983
- 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 Diacrom * Factor X Kit HA31 cleared by the FDA?
Diacrom * Factor X Kit HA31 (K832372) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 73 days after the submission was received.
What is the product code of K832372?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.