510(k) K905396
- Device
- HEMASTIX REAGENT STRIPS
- Applicant
- HERAEUS KULZER, INC.
- 510(k) number
- K905396
- Product code
- JIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-11
- Date received
- 1990-11-30
- Regulation
- 864.6550
- Classification name
- Blood, Occult, Colorimetric, In Urine
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSANNE M SAVOL
- Address
- 430 S. Beiger St. P.O. Box 2004 Mishawaka IN US 46546 46546
FDA Registration Numbers#
- 9611444
- 3006198300
- 3005360469
- 9610633
- 3003795116
- 9710094
- 1181121
- 4580
- 3004043187
- 9680746
- 3003741796
- 3010324880
- 2432235
- 1832216
- 2244821
- 1649661
- 8040374
- 3006621318
- 1036362
- 3030446844
- 2122870
- 1924669
- 3021186226
- 1417592
- 3042471840
- 3002637618
- 1061932
- 9615507
- 3008517993
- 1832816
- 3009238284
- 3010891909
- 2531491
- 3003422726
- 3003917514
- 1616487
- 3008058135
- 9610126
- 2029372
- 3012494290
- 2030633
- 3012421607
- 3009448641
- 3005841640
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JIO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2024-04-26 |
| 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 |
| K111221 | MISSION U500 URINE ANALYZER | ACON Laboratories, Inc. | 2012-01-18 |
| K082811 | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | Urit Medical Electronic Co., Ltd. | 2009-09-11 |
| K083724 | WIENER LAB. URINE STRIP 10 AND 11 | Wiener Laboratorios Saic | 2009-09-02 |
| K040703 | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS | Dirui Industrial Co., Ltd. | 2004-08-26 |
| K023297 | URS-1B (BLOOD TEST) | Teco Diagnostics | 2003-03-06 |
| K921495 | DIA STRIPS SYSTEM, MODIFIED | Symcon Intl., Inc. | 1992-07-21 |
| K913005 | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE | Remel Co. | 1991-09-16 |
| K893894 | CHARISE CHARLES REAGENT BLOOD STRIPS | Lee Import Domestic Consulting | 1989-07-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases