Rapid Bacteriuria Screen (RBS)
FDA 510(k) K862195 · New Horizons Diagnostics Co.
510(k) numberK862195
Submission
- Device name
- Rapid Bacteriuria Screen (RBS)
- Applicant
- New Horizons Diagnostics Co.
Columbia, MD, US - Received
- June 9, 1986
- Decision date
- June 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JXA – Kit, Screening, Urine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JXA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011043 | Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)JXA · Traditional | Osmetech | 11/30/2001SE |
| K981084 | UriscreenJXA · Traditional | Diatech Diagnostics,Inc. | 10/07/1998SE |
| K972676 | Urine Screening DeviceJXA · Traditional | Combact Diagnostic Systems , Ltd. | 02/23/1998SE |
| K952246 | Tri-Techin. Custom Blood And/Or Urine Transport KitJXA · Traditional | Tri-Tech, Inc. | 06/20/1995SE |
| K950257 | Multiple (Izon DBS & Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 04/14/1995SE |
| K950246 | Multiple (Izon Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 03/21/1995SESK |
| K950221 | Multiple (Izon Blood & Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 03/21/1995SEKD |
| K934759 | Culturia Macconkey-MugJXA · Traditional | Clinical Convenience Products, Inc. | 09/09/1994SE |
| K924218 | Bac-T-ScreenJXA · Traditional | Biomerieux Vitek, Inc. | 02/03/1993SE |
| K921045 | Diaslide Urine Culturing DeviceJXA · Traditional | Savyon Diagnostics , Ltd. | 09/28/1992SE |
More from Savyon Diagnostics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K932622 | Cholera Smart(Tm)GSQ · Traditional | 06/27/1995SE |
| K925190 | PyloriscreenLYR · Traditional | 03/23/1993SE |
| K922432 | CholerascreenGSQ · Traditional | 12/07/1992SE |
| K874761 | Rapid Colorimetric Direct Strep a TestGTZ · Traditional | 02/19/1988SE |
| K871226 | Syphilis Serological ReagentsGMQ · Traditional | 05/28/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | 05/13/1987SE |
| K851132 | Latex Agglutination TestGTZ · Traditional | 07/05/1985SE |
| K821362 | Improved Gono GenLIC · Traditional | 08/04/1982SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | 01/29/1982SE |
Questions and answers
When was Rapid Bacteriuria Screen (RBS) cleared by the FDA?
Rapid Bacteriuria Screen (RBS) (K862195) received a 510(k) decision of Substantially Equivalent on June 30, 1986, 21 days after the submission was received.
What is the product code of K862195?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.