FDA 510(k) Applications Submitted by K C CHEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K961629 |
04/26/1996 |
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST |
TECO DIAGNOSTICS |
| K955438 |
11/08/1995 |
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) |
TECO DIAGNOSTICS |
| K921968 |
04/27/1992 |
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST |
TECH-CO, INC. |
| K962019 |
05/23/1996 |
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST |
TECO DIAGNOSTICS |
| K954977 |
10/16/1995 |
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) |
TECO DIAGNOSTICS |
| K961864 |
05/14/1996 |
CSF/URINE TOTAL PROTEIN |
TECO DIAGNOSTICS |
| K962015 |
05/22/1996 |
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST |
TECO DIAGNOSTICS |
| K121243 |
04/25/2012 |
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER |
MEDA CO. LTD. |
| K113304 |
11/08/2011 |
BLADDER SCANNER |
MEDA CO. LTD. |
| K062644 |
09/06/2006 |
FLEXWARMER, MODELS KZ-1 AND KZ-2 |
MERLYN ASSOCIATES, INC. |
| K100024 |
01/05/2010 |
TECO DIAGNOSTICS UTI DETECTION STRIPS |
TECO DIAGNOSTICS |
| K101673 |
06/15/2010 |
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 |
TECO DIAGNOSTICS |
| K220343 |
02/07/2022 |
Nitrile Examination Gloves |
NB Medical Co., LTD |
| K072548 |
09/10/2007 |
CREATINE KINASE LIQUID REAGENT, MODEL C519-440 |
TECO DIAGNOSTICS |
| K202994 |
10/01/2020 |
InnoClip Disposable Clip Applier, InnoClip Clip Applier |
Taiwan Surgical Corporation |
| K223593 |
12/01/2022 |
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar |
Taiwan Surgical Corporation |
| K960759 |
02/26/1996 |
GONOPOX TEST KIT |
MEDTEX LABORATORIES, INC. |
| K142722 |
09/23/2014 |
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 |
Livetec GMBH |
| K210487 |
02/19/2021 |
MIPLNI YK-244 Disposable Surgical Mask |
Hunan Yuankang Biological Technology Co., Ltd |
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