JIO · Blood, Occult, Colorimetric, In Urine
Hematology · 21 CFR 864.6550 · Class 2
Overview
| Product Code | JIO |
|---|---|
| Device Name | Blood, Occult, Colorimetric, In Urine |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Classification Rationale
Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | Apr 26, 2024 | SESE |
| K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | Healgen Scientific,, LLC | Apr 17, 2012 | SESE |
| K111221 | MISSION U500 URINE ANALYZER | ACON Laboratories, Inc. | Jan 18, 2012 | SESE |
| K082811 | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | Urit Medical Electronic Co., Ltd. | Sep 11, 2009 | SESE |
| K083724 | WIENER LAB. URINE STRIP 10 AND 11 | Wiener Laboratorios Saic | Sep 2, 2009 | SESE |
| K040703 | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS | Dirui Industrial Co., Ltd. | Aug 26, 2004 | SESE |
| K023297 | URS-1B (BLOOD TEST) | Teco Diagnostics | Mar 6, 2003 | SESE |
| K921495 | DIA STRIPS SYSTEM, MODIFIED | Symcon Intl., Inc. | Jul 21, 1992 | SESE |
| K913005 | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE | Remel Co. | Sep 16, 1991 | SESE |
| K905396 | HEMASTIX REAGENT STRIPS | Heraeus Kulzer, Inc. | Feb 11, 1991 | SESE |
| K893894 | CHARISE CHARLES REAGENT BLOOD STRIPS | Lee Import Domestic Consulting | Jul 27, 1989 | SESE |
Top Applicants
- Urit Medical Electronic Co., Ltd. — 2 clearances
- ACON Laboratories, Inc. — 1 clearance
- Dirui Industrial Co., Ltd. — 1 clearance
- Healgen Scientific,, LLC — 1 clearance
- Heraeus Kulzer, Inc. — 1 clearance
