510(k) K072732
K072732 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "ORTHO T. CRUZI ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on April 15, 2009. The device falls under product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2009
- Date Received
- September 26, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunosorbent Assay, T. Cruzi
- Device Class
- Class I
- Regulation Number
- 866.3870
- Review Panel
- MI
- Submission Type