510(k) K874890 ยท JJW Urinalysis Controls (Assayed And Unassayed)
QUANTIMETRIX URINE DIPSTICK CONTROL
| Applicant | Quantimetrix Medical Industries, Hawthorne CA, US |
| Decision | Substantially Equivalent, Jan 21, 1988 |
| Received | Dec 1, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2024 | Mckesson Medical-Surgical Inc. Corporate Office 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 Open, Classified |
JJW | None listed |
| Dec 21, 2017 | Quantimetrix Corporation 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 Terminated |
JJW | None listed |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control.
The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis r Terminated |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.