HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
FDA 510(k) clearance K111999 · decided 2012-04-17
Clearance details
- K-number
- K111999
- Device name
- HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
- Applicant
- Healgen Scientific,, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-07-13
- Decision date
- 2012-04-17
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- JIO
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bellaire, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (K232317) | Urit Medical Electronic Co., Ltd. | 2024-04-26 |
| MISSION U500 URINE ANALYZER (K111221) | ACON Laboratories, Inc. | 2012-01-18 |
| URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS (K082811) | Urit Medical Electronic Co., Ltd. | 2009-09-11 |
| WIENER LAB. URINE STRIP 10 AND 11 (K083724) | Wiener Laboratorios Saic | 2009-09-02 |
| URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS (K040703) | Dirui Industrial Co., Ltd. | 2004-08-26 |
| URS-1B (BLOOD TEST) (K023297) | Teco Diagnostics | 2003-03-06 |
| DIA STRIPS SYSTEM, MODIFIED (K921495) | Symcon Intl., Inc. | 1992-07-21 |
| BACTIDROP(TM) LACTOPHENOL ANILINE BLUE (K913005) | Remel Co. | 1991-09-16 |
| HEMASTIX REAGENT STRIPS (K905396) | Heraeus Kulzer, Inc. | 1991-02-11 |
| CHARISE CHARLES REAGENT BLOOD STRIPS (K893894) | Lee Import Domestic Consulting | 1989-07-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on recall (Z-3303-2024) | Healgen Scientific Llc | 2024-09-27 |