KOAGULAB 40-A AUTOMATED COAGULATION SYS— 510(k) K823131
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K823131 for KOAGULAB 40-A AUTOMATED COAGULATION SYS, Substantially Equivalent on 1982-12-09. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code KQG
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- 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.