Uri-Three(Tm), Modification
FDA 510(k) K911846 · Culture Kits, Inc.
510(k) numberK911846
Submission
- Device name
- Uri-Three(Tm), Modification
- Applicant
- Culture Kits, Inc.
Norwich, NY, US - Received
- April 18, 1991
- Decision date
- October 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K854672 | Candi-Kit TMJSI · Traditional | 07/11/1986SE |
| K853488 | Staph KitJSI · Traditional | 08/28/1985SE |
| K851225 | Urine DuoJTZ · Traditional | 08/13/1985SE |
| K852582 | Goni-KitJSX · Traditional | 07/12/1985SE |
| K852480 | Derm-KitJSI · Traditional | 07/09/1985SE |
| K851518 | Mueller Hinton Sensitivity PlateJTZ · Traditional | 04/29/1985SE |
| K850765 | Strep-KitJSJ · Traditional | 04/24/1985SE |
| K850998 | Uri-KitJSG · Traditional | 04/01/1985SE |
Questions and answers
When was Uri-Three(Tm), Modification cleared by the FDA?
Uri-Three(Tm), Modification (K911846) received a 510(k) decision of Substantially Equivalent on October 4, 1991, 169 days after the submission was received.
What is the product code of K911846?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.