Dye-Indicator, Ph (Urinary, Non-Quantitative)
The Dye-Indicator pH Urinary Non-Quantitative Test is a clinical chemistry device that uses a pH-sensitive dye indicator to detect and semi-quantitatively assess urinary pH, typically as part of a urine dipstick or screening test panel used in routine urinalysis. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEN, regulated under 21 CFR 862.1550, within the Clinical Chemistry medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- CEN
- Device Class
- FDA class 1
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091287 | VS-SENSE TEST | Aug 31, 2009 | Substantially Equivalent | COMMON SENSE, LTD. |
| K071100 | AMNISCREEN HOME DETECTION LINER KIT | Oct 15, 2007 | Substantially Equivalent | COMMON SENSE, LTD. |
| K051727 | AIMSTICK URINE REAGENT STRIPS | Oct 26, 2005 | Substantially Equivalent | GERMAINE LABORATORIES, INC. |
| K040008 | QUICKVUE ADVANCE PH AND AMINES GLL TEST | Apr 29, 2004 | Substantially Equivalent | QUIDEL CORP. |
| K030650 | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | Apr 14, 2003 | Substantially Equivalent | URIDYNAMICS, INC. |
| K962718 | FEMEXAM TESTCARD | Feb 07, 1997 | Substantially Equivalent | LITMUS CONCEPTS, INC. |
| K840827 | KYOTEST 5V | May 14, 1984 | Substantially Equivalent | KYOTO DIAGNOSTICS, INC. |
| K830824 | URINE SCREENING KIT | Jun 12, 1983 | Substantially Equivalent | SYN-KIT, INC. |
| K830979 | HELENA BIOSTRIP PH | May 05, 1983 | Substantially Equivalent | HELENA LABORATORIES |
| K830091 | LITH A TEST TM | Feb 15, 1983 | Substantially Equivalent | LENAL CREATIVE APPROACHES, INC. |
| K822241 | FOLATE/B12 DUO-BEAD RADIOASSAY | Oct 26, 1982 | Substantially Equivalent | ABBOTT LABORATORIES |
FEI Numbers
This FDA classification entry is associated with 73 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 73 registration numbers. Click on an entry to view related FDA registrations.