ORTHO T. CRUZI ELISA TEST SYSTEM— 510(k) K072732
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K072732 for ORTHO T. CRUZI ELISA TEST SYSTEM, Substantially Equivalent on 2009-04-15. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code MIU
- Device class
- Class 1
- Regulation
- 21 CFR 866.3870
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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