Submission Details
| 510(k) Number | K052867 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 11, 2005 |
| Decision Date | December 23, 2005 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
Dec 2005
Decision
73d
Days
Class 1
Risk
About This 510(k) Submission
K052867 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS DTIBC REAGENT, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 23, 2005, 73 days after receiving the submission on October 11, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.
Device Classification
| Product Code | JMO — Ferrozine (colorimetric) Iron Binding Capacity |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1415 |
Manufacturer
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