ORTHO DNA PROBE HSV CONFIRMATION TEST— 510(k) K852360
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K852360 for ORTHO DNA PROBE HSV CONFIRMATION TEST, Substantially Equivalent on 1985-09-12. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code GQL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.