ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO— 510(k) K831670
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K831670 for ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO, Substantially Equivalent on 1983-08-24. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code JFH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code JFH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.