Submission Details
| 510(k) Number | K023309 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2002 |
| Decision Date | November 01, 2002 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
CONTROL PLASMA N
Nov 2002
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K023309 is an FDA 510(k) clearance for the CONTROL PLASMA N, 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 November 1, 2002, 29 days after receiving the submission on October 3, 2002. 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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