FDA 510(k) Applications Submitted by ROBERT WICK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K121533 |
05/24/2012 |
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET |
Tosoh BioScience, Inc. |
| K160113 |
01/19/2016 |
ST AIA-PACK hsE2 Calibrator Set |
TOSOH BIOSCIENCE, INC. |
| K150270 |
02/04/2015 |
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set |
TOSOH BIOSCIENCE, INC. |
| K140648 |
03/13/2014 |
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET |
Tosoh BioScience, Inc. |
| K131580 |
05/31/2013 |
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 |
Tosoh BioScience, Inc. |
| K123131 |
10/04/2012 |
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI |
Tosoh BioScience, Inc. |
| K143075 |
10/27/2014 |
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set |
TOSOH BIOSCIENCE, INC. |
| K143144 |
11/03/2014 |
ST AIA-PACK PROG II Calibrator Set |
Tosoh BioScience, Inc. |
| K143296 |
11/17/2014 |
AIA-PACK C-Peptide Control Set |
Tosoh BioScience, Inc. |
| K153417 |
11/25/2015 |
ST AIA-PACK PROG III Calibrator Set |
TOSOH BIOSCIENCE, INC. |
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