CEN — Dye-Indicator, Ph (Urinary, Non-Quantitative) Class I
FDA Device Classification
Classification Details
- Product Code
- CEN
- Device Class
- Class I
- Regulation Number
- 862.1550
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K091287 | common sense | VS-SENSE TEST | August 31, 2009 |
| K071100 | common sense | AMNISCREEN HOME DETECTION LINER KIT | October 15, 2007 |
| K051727 | germaine laboratories | AIMSTICK URINE REAGENT STRIPS | October 26, 2005 |
| K040008 | quidel | QUICKVUE ADVANCE PH AND AMINES GLL TEST | April 29, 2004 |
| K030650 | uridynamics | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | April 14, 2003 |
| K962718 | litmus concepts | FEMEXAM TESTCARD | February 7, 1997 |
| K840827 | kyoto diagnostics | KYOTEST 5V | May 14, 1984 |
| K830824 | syn-kit | URINE SCREENING KIT | June 12, 1983 |
| K830979 | helena laboratories | HELENA BIOSTRIP PH | May 5, 1983 |
| K830091 | lenal creative approaches | LITH A TEST TM | February 15, 1983 |
| K822241 | abbott laboratories | FOLATE/B12 DUO-BEAD RADIOASSAY | October 26, 1982 |