IRISPEC URINE CHEMISTRY CONTROL PART A AND B— 510(k) K945913
Substantially EquivalentInternational Remote Imaging Systems
FDA 510(k) clearance K945913 for IRISPEC URINE CHEMISTRY CONTROL PART A AND B, Substantially Equivalent on 1995-04-05. Applicant: International Remote Imaging Systems. Device class: 1.
Clearance details
- Applicant
- International Remote Imaging Systems
- 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
- Chartsworth, CA, US
Recent devices under product code JJW
view allMore clearances from International Remote Imaging Systems
view allRecalls naming K945913
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.