Submission Details
| 510(k) Number | K093848 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 16, 2009 |
| Decision Date | December 20, 2010 |
| Days to Decision | 369 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
PT-MULTI-CALIBRATOR, MODEL OPAT07
Dec 2010
Decision
369d
Days
Class 2
Risk
About This 510(k) Submission
K093848 is an FDA 510(k) clearance for the PT-MULTI-CALIBRATOR, MODEL OPAT07, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 20, 2010, 369 days after receiving the submission on December 16, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.
Device Classification
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5425 |
Manufacturer
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