Submission Details
| 510(k) Number | K050365 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2005 |
| Decision Date | December 27, 2005 |
| Days to Decision | 316 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
Dec 2005
Decision
316d
Days
Class 2
Risk
About This 510(k) Submission
K050365 is an FDA 510(k) clearance for the BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on December 27, 2005, 316 days after receiving the submission on February 14, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.
Device Classification
| Product Code | GGP — Test, Qualitative And Quantitative Factor Deficiency |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7290 |
Manufacturer
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