Submission Details
| 510(k) Number | K061464 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 25, 2006 |
| Decision Date | June 15, 2006 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
Jun 2006
Decision
21d
Days
Class 1
Risk
About This 510(k) Submission
K061464 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668, 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 June 15, 2006, 21 days after receiving the submission on May 25, 2006. 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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