FDA 510(k) Applications Submitted by PENNY WHITE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060139 |
01/19/2006 |
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 |
DIAGNOSTIC CHEMICALS LTD. |
| K060140 |
01/19/2006 |
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 |
DIAGNOSTIC CHEMICALS LTD. |
| K180835 |
03/30/2018 |
SEKURE Acetaminophen L3K Assay |
Sekisui Diagnostics PEI Inc. |
| K051191 |
05/10/2005 |
DCL MICROALBUMIN ASSAY, MODEL 252-20 |
DIAGNOSTIC CHEMICALS LTD. |
| K051757 |
06/29/2005 |
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 |
DIAGNOSTIC CHEMICALS LTD. |
| K202644 |
09/11/2020 |
Acetaminophen |
Sekisui Diagnostics P.E.I. INC. |
| K173206 |
10/02/2017 |
SEKURE HbA1c Assay |
Sekisui Diagnostics PEI Inc. |
| K163078 |
11/03/2016 |
DC-UIBC-CAL |
SEKISUI DIAGNOSTICS P.E.I. INC. |
| K111915 |
07/06/2011 |
MAGNESIUM ASSAY |
SEKISUI DIAGNOSTICS P.E.I. INC. |
| K081938 |
07/08/2008 |
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 |
GENZYME DIAGNOSTICS P.E.I. INC. |
| K082210 |
08/06/2008 |
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 |
GENZYME DIAGNOSTICS P.E.I. INC. |
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