FDA 510(k) Applications Submitted by LORI CREASY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K030320 |
01/30/2003 |
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET |
WAKO CHEMICALS, USA, INC. |
| K040226 |
02/02/2004 |
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET |
WAKO CHEMICALS, USA, INC. |
| K040918 |
04/08/2004 |
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 |
WAKO CHEMICALS, USA, INC. |
| K061775 |
06/23/2006 |
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K062368 |
08/14/2006 |
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 |
WAKO CHEMICALS, USA, INC. |
| K042549 |
09/20/2004 |
MULTI CHEM CAL B |
WAKO CHEMICALS, USA, INC. |
| K042550 |
09/20/2004 |
MULTI-LIPID CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K042551 |
09/20/2004 |
MULTI-CHEM CALIBRATOR A |
WAKO CHEMICALS, USA, INC. |
| K053131 |
11/08/2005 |
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 |
WAKO CHEMICALS, USA, INC. |
| K053132 |
11/08/2005 |
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 |
WAKO CHEMICALS, USA, INC. |
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