FDA 510(k) Applications Submitted by Don Lin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K251133 |
04/11/2025 |
AVEA disposable expiratory filter/water trap (11790) |
Telesair Inc. |
| K963528 |
09/04/1996 |
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) |
ALIMED, INC. |
| K982926 |
08/20/1998 |
FRESENIUS BLOOD VOLUME MONITOR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
| K963526 |
09/04/1996 |
STRAP WEDGE |
ALIMED, INC. |
| K963527 |
09/04/1996 |
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS |
ALIMED, INC. |
| K013428 |
10/16/2001 |
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM |
OHIO MEDICAL INSTRUMENT CO., INC. |
| K052383 |
08/30/2005 |
INNOCURE IMRT FILTER (COMPENSATORS) |
INNOCURE, LLC |
| K090059 |
01/09/2009 |
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM |
SASET (CHENGDU) INC. |
| K142291 |
08/18/2014 |
GMX Series Medical Air/Oxygen Blender |
GENTEC (SHANGHAI) CORPORATION |
| K191442 |
05/30/2019 |
Campylobacter Chek |
Techlab, Inc. |
| K191456 |
05/31/2019 |
Campylobacter Quik Chek |
Techlab, Inc |
| K121364 |
05/07/2012 |
SHIGA TOXIN QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
| K121411 |
05/11/2012 |
SHIGA TOXIN CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
| K103673 |
12/16/2010 |
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
| K170728 |
03/09/2017 |
E. HISTOLYTICA QUIK CHEK |
TECHLAB, Inc. |
| K171078 |
04/11/2017 |
TRI-COMBO PARASITE SCREEN |
Techlab, Inc. |
| K181379 |
05/24/2018 |
H. PYLORI QUIK CHEK |
TECHLAB, Inc. |
| K181400 |
05/29/2018 |
H. PYLORI CHEKÖ |
TECHLAB, Inc. |
| K173217 |
10/03/2017 |
CAMPYLOBACTER QUIK CHEK |
Techlab, Inc. |
| K173219 |
10/03/2017 |
CAMPYLOBACTER CHEK |
Techlab, Inc. |
|
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