Submission Details
| 510(k) Number | K072732 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2007 |
| Decision Date | April 15, 2009 |
| Days to Decision | 567 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ORTHO T. CRUZI ELISA TEST SYSTEM
Apr 2009
Decision
567d
Days
Class 1
Risk
About This 510(k) Submission
K072732 is an FDA 510(k) clearance for the ORTHO T. CRUZI ELISA TEST SYSTEM, a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I — General Controls, product code MIU), submitted by Ortho-Clinical Diagnostics, Inc. (Raritan, US). The FDA issued a Cleared decision on April 15, 2009, 567 days after receiving the submission on September 26, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.
Device Classification
| Product Code | MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3870 |
Manufacturer
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