Submission Details
| 510(k) Number | K001256 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 19, 2000 |
| Decision Date | May 24, 2000 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
CONTROL PLASMA N
May 2000
Decision
35d
Days
Class 2
Risk
About This 510(k) Submission
K001256 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 May 24, 2000, 35 days after receiving the submission on April 19, 2000. 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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