JIO — Blood, Occult, Colorimetric, In Urine Class II
FDA product code JIO covers "Blood, Occult, Colorimetric, In Urine", a Class II medical device regulated under 21 CFR 864.6550. Submissions are reviewed by the Hematology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIO
- Device Class
- Class II
- Regulation Number
- 864.6550
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232317 | urit medical electronic co | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urin | April 26, 2024 |
| K111999 | healgen scientific | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS | April 17, 2012 |
| K111221 | acon laboratories | MISSION U500 URINE ANALYZER | January 18, 2012 |
| K082811 | urit medical electronic co | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANA | September 11, 2009 |
| K083724 | wiener laboratorios saic | WIENER LAB. URINE STRIP 10 AND 11 | September 2, 2009 |
| K040703 | dirui industrial co | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS | August 26, 2004 |
| K023297 | teco diagnostics | URS-1B (BLOOD TEST) | March 6, 2003 |
| K921495 | symcon intl | DIA STRIPS SYSTEM, MODIFIED | July 21, 1992 |
| K913005 | remel | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE | September 16, 1991 |
| K905396 | heraeus kulzer | HEMASTIX REAGENT STRIPS | February 11, 1991 |
| K893894 | lee import domestic consulting | CHARISE CHARLES REAGENT BLOOD STRIPS | July 27, 1989 |