FDA 510(k) Applications Submitted by OLA ANDERSON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050365 |
02/14/2005 |
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 |
HYPHEN BIOMED |
| K050367 |
02/14/2005 |
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 |
HYPHEN BIOMED |
| K071255 |
05/04/2007 |
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A |
HYPHEN BIOMED |
| K051472 |
06/03/2005 |
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR |
HYPHEN BIOMED |
| K043007 |
11/01/2004 |
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 |
HYPHEN BIOMED |
| K043451 |
12/14/2004 |
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR |
HYPHEN BIOMED |
| K083729 |
12/16/2008 |
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN |
ANIARA DIAGNOSTICA ,LLC |
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