CEN
11 FDA 510(k) clearances · Product code
91 daysmedian time to decision
179 days90th percentile
11clearances measured
FDA profile
- Official device name
- Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VS-SENSE TEST (K091287) | Common Sense , Ltd. | 2009-08-31 |
| AMNISCREEN HOME DETECTION LINER KIT (K071100) | Common Sense , Ltd. | 2007-10-15 |
| AIMSTICK URINE REAGENT STRIPS (K051727) | Germaine Laboratories, Inc. | 2005-10-26 |
| QUICKVUE ADVANCE PH AND AMINES GLL TEST (K040008) | Quidel Corp. | 2004-04-29 |
| STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (K030650) | Uridynamics, Inc. | 2003-04-14 |
| FEMEXAM TESTCARD (K962718) | Litmus Concepts, Inc. | 1997-02-07 |
| KYOTEST 5V (K840827) | Kyoto Diagnostics, Inc. | 1984-05-14 |
| URINE SCREENING KIT (K830824) | Syn-Kit, Inc. | 1983-06-12 |
| HELENA BIOSTRIP PH (K830979) | Helena Laboratories | 1983-05-05 |
| LITH A TEST TM (K830091) | Lenal Creative Approaches, Inc. | 1983-02-15 |
| FOLATE/B12 DUO-BEAD RADIOASSAY (K822241) | Abbott Laboratories | 1982-10-26 |
Track CEN automatically
Every clearance here is in the API, with alerts when new ones post.