FDA product code CEN: Dye-Indicator, Ph (Urinary, Non-Quantitative)
CEN is the FDA product code for dye-indicator, ph (urinary, non-quantitative). It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under CEN, from 10 different applicants. The average 510(k) review took 102 days (median 91). FDA has posted 5 recalls for CEN devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| Device class | Class I |
| Regulation | 21 CFR 862.1550 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEN clearance
Top CEN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Common Sense , Ltd. | 2 | 2009-08-31 |
| Germaine Laboratories, Inc. | 1 | 2005-10-26 |
| Quidel Corp. | 1 | 2004-04-29 |
| Uridynamics, Inc. | 1 | 2003-04-14 |
| Litmus Concepts, Inc. | 1 | 1997-02-07 |
5 more applicants have CEN clearances. See the full list in Caduvo.
Most recent CEN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091287 | Common Sense , Ltd. | VS-SENSE TEST | 2009-08-31 | 122 |
| K071100 | Common Sense , Ltd. | AMNISCREEN HOME DETECTION LINER KIT | 2007-10-15 | 179 |
| K051727 | Germaine Laboratories, Inc. | AIMSTICK URINE REAGENT STRIPS | 2005-10-26 | 120 |
| K040008 | Quidel Corp. | QUICKVUE ADVANCE PH AND AMINES GLL TEST | 2004-04-29 | 118 |
| K030650 | Uridynamics, Inc. | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | 2003-04-14 | 45 |
Recalls for CEN devices
5 product recalls in 4 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code CEN?
CEN is the FDA product code for dye-indicator, ph (urinary, non-quantitative). It is a Class I device, regulated under 21 CFR 862.1550 and reviewed by the Clinical Chemistry panel.
What device class is CEN?
Class I, regulation 21 CFR 862.1550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEN?
Across 11 cleared submissions the average was 102 days from receipt to decision (median 91).
Which companies have the most CEN clearances?
Common Sense , Ltd. (2); Germaine Laboratories, Inc. (1); Quidel Corp. (1); Uridynamics, Inc. (1); Litmus Concepts, Inc. (1).
Have CEN devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code CEN
- Run a recall and safety report across every CEN manufacturer
- Watch product code CEN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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