Vista(R) Human Follicle-Stim Hormone(Hfsh) Assay
FDA 510(k) K926422 · Syva Co.
510(k) numberK926422
Submission
- Device name
- Vista(R) Human Follicle-Stim Hormone(Hfsh) Assay
- Applicant
- Syva Co.
San Jose, CA, US - Received
- December 23, 1992
- Decision date
- June 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGJ – Fluid, Diluting, White-Cell
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8200
- Specialty
- Hematology
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Questions and answers
When was Vista(R) Human Follicle-Stim Hormone(Hfsh) Assay cleared by the FDA?
Vista(R) Human Follicle-Stim Hormone(Hfsh) Assay (K926422) received a 510(k) decision of Substantially Equivalent on June 2, 1993, 161 days after the submission was received.
What is the product code of K926422?
The FDA product code is GGJ – Fluid, Diluting, White-Cell, a Class I (low risk) device regulated under 21 CFR 864.8200.