FDA 510(k) Applications Submitted by PAIVI SORMUNEN
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K110035 |
01/05/2011 |
INDIKO |
THERMO FISHER SCIENTIFIC OY |
K070824 |
03/26/2007 |
CREATININE (ENZYMATIC) |
THERMO FISHER SCIENTIFIC OY |
K061107 |
04/20/2006 |
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 |
THERMO ELECTRON OY |
K071340 |
05/14/2007 |
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL |
THERMO FISHER SCIENTIFIC OY |
K071580 |
06/08/2007 |
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL |
THERMO FISHER SCIENTIFIC OY |
K063086 |
10/10/2006 |
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS |
THERMO ELECTRON OY |
K063131 |
10/13/2006 |
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS |
THERMO ELECTRON OY |
K063145 |
10/16/2006 |
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS |
THERMO ELECTRON OY |
K063150 |
10/16/2006 |
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL |
THERMO ELECTRON OY |
K063209 |
10/23/2006 |
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL |
THERMO ELECTRON OY |
K073191 |
11/13/2007 |
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
K073295 |
11/23/2007 |
UREA/BUN, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
K073355 |
11/29/2007 |
CALCIUM, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
K063647 |
12/07/2006 |
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH |
THERMO ELECTRON OY |
K063705 |
12/13/2006 |
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL |
THERMO ELECTRON OY |
K073612 |
12/21/2007 |
URIC ACID (AOX), SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
K063838 |
12/26/2006 |
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH |
THERMO ELECTRON OY |
|
|