URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING— 510(k) K001810
Substantially EquivalentFlexsite Diagnostics, Inc.
FDA 510(k) clearance K001810 for URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING, Substantially Equivalent on 2000-08-14. Applicant: Flexsite Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Flexsite Diagnostics, Inc.
- Product code
- Code JIR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1645
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code JIR
view allMore clearances from Flexsite Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.