Lyfo Kwik(Tm) Rus Kit
FDA 510(k) K870731 · Micro-Bio-Logics
510(k) numberK870731
Submission
- Device name
- Lyfo Kwik(Tm) Rus Kit
- Applicant
- Micro-Bio-Logics
St. Cloud, MN, US - Received
- February 25, 1987
- Decision date
- June 17, 1987
- 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 |
|---|---|---|
| K861312 | Lyfo-Kwik (TM) Coagulase PlasmaJTL · Traditional | 04/18/1986SE |
| K861022 | Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional | 04/04/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | 02/20/1986SE |
| K855198 | Indi Kwik (TM) Co/Two KitJTR · Traditional | 01/14/1986SE |
| K852998 | Neisseria - Kwik PlusJSX · Traditional | 07/23/1985SE |
| K851978 | Lyfo-Kwik Omi KitJSS · Traditional | 06/04/1985SE |
| K844014 | Ono/Co-Two (TM) SystemsJTY · Traditional | 10/31/1984SE |
| K842129 | Lyfo-Disk MicroorganismsJTR · Traditional | 07/03/1984SE |
Questions and answers
When was Lyfo Kwik(Tm) Rus Kit cleared by the FDA?
Lyfo Kwik(Tm) Rus Kit (K870731) received a 510(k) decision of Substantially Equivalent on June 17, 1987, 112 days after the submission was received.
What is the product code of K870731?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.