CEN · Dye-Indicator, Ph (Urinary, Non-Quantitative)
Clinical Chemistry · 21 CFR 862.1550 · Class 1
Overview
| Product Code | CEN |
|---|---|
| Device Name | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| Regulation | 21 CFR 862.1550 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091287 | VS-SENSE TEST | Common Sense , Ltd. | Aug 31, 2009 | SESE |
| K071100 | AMNISCREEN HOME DETECTION LINER KIT | Common Sense , Ltd. | Oct 15, 2007 | SESE |
| K051727 | AIMSTICK URINE REAGENT STRIPS | Germaine Laboratories, Inc. | Oct 26, 2005 | SESE |
| K040008 | QUICKVUE ADVANCE PH AND AMINES GLL TEST | Quidel Corp. | Apr 29, 2004 | SESE |
| K030650 | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | Uridynamics, Inc. | Apr 14, 2003 | SESE |
| K962718 | FEMEXAM TESTCARD | Litmus Concepts, Inc. | Feb 7, 1997 | SESE |
| K840827 | KYOTEST 5V | Kyoto Diagnostics, Inc. | May 14, 1984 | SESE |
| K830824 | URINE SCREENING KIT | Syn-Kit, Inc. | Jun 12, 1983 | SESE |
| K830979 | HELENA BIOSTRIP PH | Helena Laboratories | May 5, 1983 | SESE |
| K830091 | LITH A TEST TM | Lenal Creative Approaches, Inc. | Feb 15, 1983 | SESE |
| K822241 | FOLATE/B12 DUO-BEAD RADIOASSAY | Abbott Laboratories | Oct 26, 1982 | SESE |
Top Applicants
- Common Sense , Ltd. — 2 clearances
- Abbott Laboratories — 1 clearance
- Germaine Laboratories, Inc. — 1 clearance
- Helena Laboratories — 1 clearance
- Kyoto Diagnostics, Inc. — 1 clearance
