FDA 510(k) Applications Submitted by LOIS NAKAYAMA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020489 |
02/13/2002 |
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE |
TOSOH MEDICS, INC. |
| K010796 |
03/16/2001 |
AIA-PACK BRCA, ST AIA PACK BRCA |
TOSOH MEDICS, INC. |
| K991252 |
04/13/1999 |
AIA-PACK FT3 ASSAY |
TOSOH MEDICS, INC. |
| K011434 |
05/10/2001 |
G7 AUTOMATED HPLC ANALYZER |
TOSOH MEDICS, INC. |
| K102029 |
07/19/2010 |
PEAK PULSAR II GENERATOR MODEL PS100-102 |
PEAK SURGICAL, INC. |
| K012820 |
08/23/2001 |
AIA-PACK CTNI 2ND-GEN ASSAY |
TOSOH MEDICS, INC. |
| K023091 |
09/17/2002 |
ST AIA-PACK TESTOSTERONE ASSAY |
TOSOH MEDICS, INC. |
| K083415 |
11/18/2008 |
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
| K023891 |
11/22/2002 |
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY |
TOSOH MEDICS, INC. |
| K023893 |
11/22/2002 |
ST AIA-PACK CEA ENZYME IMMUNOASSAY |
TOSOH MEDICS, INC. |
| K023894 |
11/22/2002 |
ST AIA-PACK AFP ENZYME IMMUNOASSAY |
TOSOH MEDICS, INC. |
| K093695 |
11/30/2009 |
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
| K163367 |
11/30/2016 |
GenetiSure Dx Postnatal Assay |
Agilent Technologies, Inc. |
| K103775 |
12/27/2010 |
PEAK SUCTION COAGULATOR |
PEAK SURGICAL, INC. |
|
|
