Product code CEN— Clinical Chemistry
AIMSTICK URINE REAGENT STRIPS
- Classification name
- Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1550
- Advisory panel
- Clinical Chemistry
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code CEN
FDA has cleared devices under product code CEN between 1982 and 2009, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2009
- 2007
- 2005
- 2004
- 2003
- 1997
- 1984
- 1983
- 1982
Top applicants under product code CEN
Recent clearances under product code CEN
- K091287 — VS-SENSE TEST
- K071100 — AMNISCREEN HOME DETECTION LINER KIT
- K051727 — AIMSTICK URINE REAGENT STRIPS
- K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST
- K030650 — STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
- K962718 — FEMEXAM TESTCARD
- K840827 — KYOTEST 5V
- K830824 — URINE SCREENING KIT
- K830979 — HELENA BIOSTRIP PH
- K830091 — LITH A TEST TM
- K822241 — FOLATE/B12 DUO-BEAD RADIOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.