FDA 510(k) Applications Submitted by ANDREW LOC B LE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230506 |
02/24/2023 |
PureLift Pro Edition |
Xtreem Pulse |
| K221443 |
05/18/2022 |
PureLift Pro Plus |
Xtreem Pulse LLC |
| K173483 |
11/13/2017 |
Pure Flow External Counter-Pulsation Device |
Xtreem Pulse, LLC |
| K190269 |
02/08/2019 |
PureLift |
Xtreem Pulse, LLC |
| K183012 |
10/31/2018 |
vascuCAP |
Elucid Bioimaging Inc. |
| K961118 |
03/20/1996 |
MAXIM PF MODELS 033-581/033-590 |
TELECTRONICS PACING SYSTEMS, INC. |
| K012512 |
08/06/2001 |
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM |
RADIANT MEDICAL |
| K042388 |
09/02/2004 |
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE |
RADIANT MEDICAL |
| K024327 |
12/26/2002 |
SETPOINT ENDOVASCULAR TEMPERATURE PROBE |
RADIANT MEDICAL |
| K050644 |
03/14/2005 |
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT |
VANCOUVER BIOTECH LTD. |
| K093444 |
11/05/2009 |
EXAPACS |
MEDINCOM TECHNOLOGY CORP |
| K040407 |
02/17/2004 |
QUICKELISA ANTHRAX-PA KIT |
IMMUNETICS, INC. |
| K010324 |
02/02/2001 |
STA-QUALITY HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
| K010350 |
02/05/2001 |
STA -CALIBRATOR HBPM/LMWH KIT |
DIAGNOSTICA STAGO, INC. |
| K962671 |
07/09/1996 |
STA-VWF CALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
| K962674 |
07/09/1996 |
STA - VWF CONTROL [N]+[P] KIT |
AMERICAN BIOPRODUCTS CO. |
| K962675 |
07/09/1996 |
STA - LIATEST VWF TEST KIT |
AMERICAN BIOPRODUCTS CO. |
| K964718 |
11/25/1996 |
STA D-DI CALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
| K964728 |
11/25/1996 |
STA-LIATEST D-DI TEST KIT |
AMERICAN BIOPRODUCTS CO. |
| K964716 |
11/25/1996 |
STA LIATEST CONTROL [N]+[P] KIT |
AMERICAN BIOPRODUCTS CO. |
| K172080 |
07/10/2017 |
Photoelectric Therapy System |
Xstrahl Ltd. |
| K981858 |
05/27/1998 |
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW |
ATLANTIS COMPONENTS, INC. |
| K101474 |
05/28/2010 |
MD VISION SYSTEM |
PERKINS HEALTHCARE TECHNOLOGIES |
| K954505 |
09/28/1995 |
EZ STIM |
LIFE-TECH INTL., INC. |
| K991063 |
03/31/1999 |
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 |
IMMUNETICS, INC. |
| K991062 |
03/31/1999 |
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 |
IMMUNETICS, INC. |
| K003754 |
12/05/2000 |
IMMUNETICS C6 LYME ELISA KIT |
IMMUNETICS, INC. |
| K163071 |
11/02/2016 |
vascuCAP |
Elucid Bioimaging, Inc. |
| K983460 |
09/30/1998 |
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER |
AMERICAN BIOPRODUCTS CO. |
| K010455 |
01/29/2001 |
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN |
DIAGNOSTICA-STAGO |
| K010963 |
03/30/2001 |
STA-LIATEST FREE PROTEIN S TEST KIT |
DIAGNOSTICA STAGO, INC. |
| K971519 |
04/25/1997 |
ASSERACHROM TPA TEST KIT |
AMERICAN BIOPRODUCTS CO. |
| K955040 |
11/03/1995 |
AT-III CONTROL PLASMA KIT |
AMERICAN BIOPRODUCTS CO. |
| K003767 |
12/06/2000 |
ASSERACHROM HPIA TEST KIT |
DIAGNOSTICA STAGO, INC. |
| K961579 |
04/24/1996 |
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER |
AMERICAN BIOPRODUCTS CO. |
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