Vista Folate Assay
FDA 510(k) K934121 · Syva Co.
510(k) numberK934121
Submission
- Device name
- Vista Folate Assay
- Applicant
- Syva Co.
San Jose, CA, US - Received
- August 25, 1993
- Decision date
- October 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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| K082340 | Roche Elecsys Folate III, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…CGN · Traditional | Roche Diagnostics Corp. | 06/19/2009SE |
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Questions and answers
When was Vista Folate Assay cleared by the FDA?
Vista Folate Assay (K934121) received a 510(k) decision of Substantially Equivalent on October 22, 1993, 58 days after the submission was received.
What is the product code of K934121?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.