ORTHO* RSV ANTIGEN ELISA TEST SYS— 510(k) K842047
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K842047 for ORTHO* RSV ANTIGEN ELISA TEST SYS, Substantially Equivalent on 1984-10-05. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code LKT
- Device class
- Class 1
- Regulation
- 21 CFR 866.3480
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
Recent devices under product code LKT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.