Submission Details
| 510(k) Number | K120609 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 29, 2012 |
| Decision Date | September 07, 2012 |
| Days to Decision | 191 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Sep 2012
Decision
191d
Days
Class 1
Risk
About This 510(k) Submission
K120609 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS DHDL SLIDES, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 7, 2012, 191 days after receiving the submission on February 29, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.
Device Classification
| Product Code | LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1475 |
Manufacturer
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