ORTHO B-HCG SLIDE TEST FOR PREGNANCY— 510(k) K833137
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K833137 for ORTHO B-HCG SLIDE TEST FOR PREGNANCY, Substantially Equivalent on 1984-01-18. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
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