ORTHOKROME* ANTIPLASMIN— 510(k) K900397
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K900397 for ORTHOKROME* ANTIPLASMIN, Substantially Equivalent on 1990-03-15. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.