510(k) K101852 ยท KQO Automated Urinalysis System
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
| Applicant | Iris International Inc., A Division of Iris Iris I, Chatsworth CA, US |
| Decision | Substantially Equivalent, Mar 23, 2011 |
| Received | Jul 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101852
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2020 | Beckman Coulter Inc. iChemVELOCITY Urine Chemistry System- Terminated |
KQO | None listed |
| Feb 17, 2020 | Beckman Coulter, Inc. iChemVELOCITY Strips, Catalog 800-7212 Terminated |
KQO | None listed |
| Nov 7, 2019 | Beckman Coulter Inc. iChem VELOCITY Urine Chemistry Analyzer Terminated |
KQO | None listed |
| Oct 28, 2019 | Beckman Coulter Inc. iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Terminated |
KQO | None listed |
| Oct 18, 2018 | Beckman Coulter Inc. iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany. Terminated |
KQO | None listed |
| Apr 27, 2018 | Beckman Coulter Inc. iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001.
The iChemVELOCITY automated urine chem Terminated |
KQO | None listed |
| Mar 2, 2018 | Beckman Coulter Inc. BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800-
7106, 800-3049, 800-3050, 800-3079, 800-3080,
800-7190, 800-7713, 800-7714, 800-77 Terminated |
KQO | None listed |
| Dec 4, 2017 | Beckman Coulter Inc. iChem VELOCITY Urine Chemistry Strips, REF 800-7212
Product Usage:
The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis pr Terminated |
LJX | None listed |
| Mar 1, 2017 | Beckman Coulter Inc. iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061.
The iChem Velocity automated u Terminated |
KQO | None listed |
| Jan 13, 2016 | Beckman Coulter Inc. iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720
iChem VELOCITY Urine Chemistry Strip Terminated |
KQO | None listed |
| Aug 21, 2015 | Iris Diagnostics iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to a Terminated |
KQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.