Resubmitted Utiscreen(Tm) Bacterial Atp Test
FDA 510(k) K883385 · Los Alamos Diagnostics
510(k) numberK883385
Submission
- Device name
- Resubmitted Utiscreen(Tm) Bacterial Atp Test
- Applicant
- Los Alamos Diagnostics
Los Alamos, NM, US - Received
- August 9, 1988
- Decision date
- September 7, 1988
- 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 |
|---|---|---|
| K896117 | Modified Model 535(TM) LuminometerJJQ · Traditional | 11/30/1989SE |
| K882608 | Lad Model 633 LuminometerJJQ · Traditional | 08/29/1988SE |
| K881439 | Modified Utiscreen(Tm) Bacterial Atp Test SystemJXA · Traditional | 04/28/1988SE |
| K874262 | Lad Model 735 LuminometerJJQ · Traditional | 11/27/1987SE |
| K864202 | Utiscreen(R) Bacterial Atp TestJXA · Traditional | 02/13/1987SE |
| K864201 | Lad Model 535 LuminometerJJQ · Traditional | 01/13/1987SE |
Questions and answers
When was Resubmitted Utiscreen(Tm) Bacterial Atp Test cleared by the FDA?
Resubmitted Utiscreen(Tm) Bacterial Atp Test (K883385) received a 510(k) decision of Substantially Equivalent on September 7, 1988, 29 days after the submission was received.
What is the product code of K883385?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.