510(k) K061559 ยท CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
ACON URINALYSIS REAGENT STRIPS
| Applicant | Acon Laboratories Co., San Antonio TX, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | Jun 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2018 | Clarity Diagnostics Llc Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG
Product Usage:
Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analyt Terminated |
CDM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.