FDA 510(k) Applications Submitted by CYNTHIA SINCLAIR
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080008 |
01/02/2008 |
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET |
BIO-RAD LABORATORIES, INC. |
| K120611 |
02/29/2012 |
SONY PVM-2551MD OLED MONITOR |
SONY ELECTRONICS, INC. |
| K070704 |
03/13/2007 |
TRILOGY ANALYZER |
DREW SCIENTIFIC, INC. |
| K121039 |
04/05/2012 |
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
COPAN FLOCK TECHNOLOGIES |
| K061301 |
05/10/2006 |
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM |
COPAN DIAGNOSTICS, INC. |
| K061886 |
07/03/2006 |
ACTIM PROM AND CONTROLS |
MEDIX BIOCHEMICA |
| K042970 |
10/28/2004 |
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM |
COPAN DIAGNOSTICS, INC. |
| K113203 |
10/31/2011 |
SONY LMD-2451MT LCD MONITOR |
SONY ELECTRONICS, INC. |
| K083522 |
11/26/2008 |
SONY UP-DF750 DIGITAL FILM IMAGER |
SONY ELECTRONICS, INC. |
| K050014 |
01/03/2005 |
HEMONIR TM |
NIR DIAGNOSTICS, INC. |
| K980279 |
01/26/1998 |
SONY DXC-LS1 COLOR VIDEO CAMERA |
SONY MEDICAL ELECTRONICS CO. |
| K970999 |
03/19/1997 |
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR |
SONY MEDICAL SYSTEMS |
| K961680 |
05/01/1996 |
SONY DKR-700 DIGITAL STILL RECORDER |
SONY MEDICAL SYSTEMS |
| K972229 |
06/13/1997 |
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM |
HEARTWARE, INC. |
| K972448 |
06/30/1997 |
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL |
COPAN ITALIA SPA |
| K972449 |
06/30/1997 |
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL |
COPAN ITALIA SPA |
| K041882 |
07/12/2004 |
FLOWCARE SYSTEM |
POINTCARE TECHNOLOGIES INC. |
| K092817 |
09/14/2009 |
POC-AS10 AUTO SAMPLER |
OTSUKA PHARMACEUTICAL CO., LTD. |
| K052716 |
09/29/2005 |
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT |
OTSUKA PHARMACEUTICAL CO., LTD. |
| K013371 |
10/11/2001 |
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM |
OTSUKA PHARMACEUTICAL CO., LTD. |
| K024188 |
12/19/2002 |
UP-DF500 FILMSTATION DIGITAL FILM IMAGER |
SONY MEDICAL SYSTEMS |
| K041148 |
05/03/2004 |
POCONE INFRARED SPECTROPHOTOMETER |
OTSUKA PHARMACEUTICAL CO., LTD. |
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