FDA Product Code
FDA Product Code JIO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6550
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2024-04-26 | Traditional | PDF ↗ |
| K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | Healgen Scientific,, LLC | 2012-04-17 | Traditional | PDF ↗ |
| K111221 | MISSION U500 URINE ANALYZER | ACON Laboratories, Inc. | 2012-01-18 | Traditional | PDF ↗ |
| K082811 | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | Urit Medical Electronic Co., Ltd. | 2009-09-11 | Traditional | PDF ↗ |
| K083724 | WIENER LAB. URINE STRIP 10 AND 11 | Wiener Laboratorios Saic | 2009-09-02 | Traditional | PDF ↗ |
| K040703 | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS | Dirui Industrial Co., Ltd. | 2004-08-26 | Traditional | PDF ↗ |
| K023297 | URS-1B (BLOOD TEST) | Teco Diagnostics | 2003-03-06 | Traditional | PDF ↗ |
| K921495 | DIA STRIPS SYSTEM, MODIFIED | Symcon Intl., Inc. | 1992-07-21 | Traditional | PDF ↗ |
| K913005 | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE | Remel Co. | 1991-09-16 | Traditional | PDF ↗ |
| K905396 | HEMASTIX REAGENT STRIPS | Heraeus Kulzer, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K893894 | CHARISE CHARLES REAGENT BLOOD STRIPS | Lee Import Domestic Consulting | 1989-07-27 | Traditional | PDF ↗ |
Product code JIO · Class II · Hematology. Data: openFDA.