FDA 510(k) Applications Submitted by HYUN JOON OH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120351 |
02/06/2012 |
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA |
i-SENS, Inc. |
| K120759 |
03/13/2012 |
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION |
i-SENS, Inc. |
| K080923 |
04/02/2008 |
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB |
i-SENS, Inc. |
| K121133 |
04/13/2012 |
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
| K121654 |
06/05/2012 |
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION |
i-SENS, Inc. |
| K083468 |
11/24/2008 |
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) |
i-SENS, Inc. |
| K100937 |
04/05/2010 |
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE |
i-SENS, Inc. |
| K103278 |
11/05/2010 |
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION |
i-SENS, Inc. |
| K170232 |
01/25/2017 |
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer |
BODITECH MED INC. |
| K160140 |
01/21/2016 |
DENTRIa series |
HDX WILL CORP. |
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