BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202— 510(k) K050365

Clearance details

Applicant

Hyphen Biomed

Product code

Code GGP

Device class

Class 2

Regulation

21 CFR 864.7290

Advisory panel

Hematology

Date received

2005-02-14

Decision date

2005-12-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mason, OH, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050365.