Submission Details
| 510(k) Number | K081411 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 20, 2008 |
| Decision Date | June 30, 2008 |
| Days to Decision | 41 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
Jun 2008
Decision
41d
Days
Class 2
Risk
About This 510(k) Submission
K081411 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 30, 2008, 41 days after receiving the submission on May 20, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.
Device Classification
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1665 |
Manufacturer
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