ORTHO ABNORMAL PROTEIN C CONTROL PLASMA— 510(k) K901233
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K901233 for ORTHO ABNORMAL PROTEIN C CONTROL PLASMA, Substantially Equivalent on 1990-04-11. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code GGC
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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