CEN · Class I · 21 CFR 862.1550

FDA Product Code CEN: Dye-indicator, Ph (urinary, Non-quantitative)

Leading manufacturers include Common Sense , Ltd., Quidel Corp. and Germaine Laboratories, Inc..

11
Total
11
Cleared
102d
Avg days
1982
Since

FDA 510(k) Cleared Dye-indicator, Ph (urinary, Non-quantitative) Devices (Product Code CEN)

11 devices
1–11 of 11
Cleared Aug 31, 2009
VS-SENSE TEST
K091287
Common Sense , Ltd.
Chemistry · 122d
Cleared Oct 15, 2007
AMNISCREEN HOME DETECTION LINER KIT
K071100
Common Sense , Ltd.
Chemistry · 179d
Cleared Oct 26, 2005
AIMSTICK URINE REAGENT STRIPS
K051727
Germaine Laboratories, Inc.
Chemistry · 120d
Cleared Apr 29, 2004
QUICKVUE ADVANCE PH AND AMINES GLL TEST
K040008
Quidel Corp.
Chemistry · 118d
Cleared Feb 07, 1997
FEMEXAM TESTCARD
K962718
Litmus Concepts, Inc.
Chemistry · 210d
Cleared Jun 12, 1983
URINE SCREENING KIT
K830824
Syn-Kit, Inc.
Microbiology · 89d
Cleared May 05, 1983
HELENA BIOSTRIP PH
K830979
Helena Laboratories
Chemistry · 37d
Cleared Oct 26, 1982
FOLATE/B12 DUO-BEAD RADIOASSAY
K822241
Abbott Laboratories
Chemistry · 91d

About Product Code CEN - Regulatory Context