Submission Details
| 510(k) Number | K042941 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 2004 |
| Decision Date | December 02, 2004 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
Dec 2004
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K042941 is an FDA 510(k) clearance for the DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS, a Plasma, Control, Normal (Class II — Special Controls, product code GIZ), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 2, 2004, 38 days after receiving the submission on October 25, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.
Device Classification
| Product Code | GIZ — Plasma, Control, Normal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5425 |
Manufacturer
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