Submission Details
| 510(k) Number | K940209 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 1994 |
| Decision Date | May 11, 1995 |
| Days to Decision | 482 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
May 1995
Decision
482d
Days
Class 2
Risk
About This 510(k) Submission
K940209 is an FDA 510(k) clearance for the ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on May 11, 1995, 482 days after receiving the submission on January 14, 1994. 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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