VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY— 510(k) K926342
Substantially EquivalentSyva Co.
FDA 510(k) clearance K926342 for VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY, Substantially Equivalent on 1993-02-17. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Product code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
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Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.