Panels › Clinical Chemistry › Product code CEN · Class 1
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Regulation 862.1550
0510(k)s in 12 months (11 all time)
4recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in CEN
| Company | 510(k)s | Recalls |
|---|---|---|
| Common Sense , Ltd. | 2 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 2 |
| Abbott Laboratories | 1 | 0 |
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| DFI Co., Ltd. | 0 | 1 |
| Germaine Laboratories, Inc. | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Kyoto Diagnostics, Inc. | 1 | 0 |
| Lenal Creative Approaches, Inc. | 1 | 0 |
| Litmus Concepts, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2009 | K091287 | VS-SENSE TEST Common Sense , Ltd. | CEN |
| Oct 15, 2007 | K071100 | AMNISCREEN HOME DETECTION LINER KIT Common Sense , Ltd. | CEN |
| Oct 26, 2005 | K051727 | AIMSTICK URINE REAGENT STRIPS Germaine Laboratories, Inc. | CEN |
| Apr 29, 2004 | K040008 | QUICKVUE ADVANCE PH AND AMINES GLL TEST Quidel Corp. | CEN |
| Apr 14, 2003 | K030650 | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS Uridynamics, Inc. | CEN |
| Feb 7, 1997 | K962718 | FEMEXAM TESTCARD Litmus Concepts, Inc. | CEN |
| May 14, 1984 | K840827 | KYOTEST 5V Kyoto Diagnostics, Inc. | CEN |
| Jun 12, 1983 | K830824 | URINE SCREENING KIT Syn-Kit, Inc. | CEN |
| May 5, 1983 | K830979 | HELENA BIOSTRIP PH Helena Laboratories | CEN |
| Feb 15, 1983 | K830091 | LITH A TEST TM Lenal Creative Approaches, Inc. | CEN |
| Oct 26, 1982 | K822241 | FOLATE/B12 DUO-BEAD RADIOASSAY Abbott Laboratories | CEN |
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