Submission Details
| 510(k) Number | K082099 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 25, 2008 |
| Decision Date | August 21, 2008 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
Aug 2008
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K082099 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 21, 2008, 27 days after receiving the submission on July 25, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.
Device Classification
| Product Code | CGZ — Electrode, Ion-specific, Chloride |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1170 |
Manufacturer
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