FDA 510(k) Applications for Medical Device Product Code "CEN"
(Dye-Indicator, Ph (Urinary, Non-Quant.))

FDA 510(k) Number Applicant Device Name Decision Date
K822241 ABBOTT LABORATORIES FOLATE/B12 DUO-BEAD RADIOASSAY 10/26/1982
K071100 COMMON SENSE, LTD. AMNISCREEN HOME DETECTION LINER KIT 10/15/2007
K091287 COMMON SENSE, LTD. VS-SENSE TEST 08/31/2009
K051727 GERMAINE LABORATORIES, INC. AIMSTICK URINE REAGENT STRIPS 10/26/2005
K830979 HELENA LABORATORIES HELENA BIOSTRIP PH 05/05/1983
K840827 KYOTO DIAGNOSTICS, INC. KYOTEST 5V 05/14/1984
K830091 LENAL CREATIVE APPROACHES, INC. LITH A TEST TM 02/15/1983
K962718 LITMUS CONCEPTS, INC. FEMEXAM TESTCARD 02/07/1997
K040008 QUIDEL CORP. QUICKVUE ADVANCE PH AND AMINES GLL TEST 04/29/2004
K830824 SYN-KIT, INC. URINE SCREENING KIT 06/12/1983
K030650 URIDYNAMICS, INC. STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS 04/14/2003


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