CYTOTECH HSV IGG ENZYME IMMUNOASSAY— 510(k) K862838
Substantially EquivalentCytotech, Inc.
FDA 510(k) clearance K862838 for CYTOTECH HSV IGG ENZYME IMMUNOASSAY, Substantially Equivalent on 1986-12-09. Applicant: Cytotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Cytotech, Inc.
- Product code
- Code GCO
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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