QUANTIMETRIX URINE DIPSTICK CONTROL— 510(k) K874890
Substantially EquivalentQuantimetrix Medical Industries
FDA 510(k) clearance K874890 for QUANTIMETRIX URINE DIPSTICK CONTROL, Substantially Equivalent on 1988-01-21. Applicant: Quantimetrix Medical Industries. Device class: 1.
Clearance details
- Applicant
- Quantimetrix Medical Industries
- Product code
- Code JJW
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hawthorne, CA, US
Recent devices under product code JJW
view allMore clearances from Quantimetrix Medical Industries
view allRecalls naming K874890
K-number listed on FDA's recall record- Z-0138-2025 — Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
- Z-2257-2018 — Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874890.
Data sourced from openFDA. This site is unofficial and independent of the FDA.