Slide Culture U 'Eiken'
FDA 510(k) K861631 · Syn-Kit, Inc.
510(k) numberK861631
Submission
- Device name
- Slide Culture U 'Eiken'
- Applicant
- Syn-Kit, Inc.
Chatsworth, CA, US - Received
- April 29, 1986
- Decision date
- June 10, 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 |
|---|---|---|
| K861098 | Seroiden Strepto Kit 'Eiken'GTZ · Traditional | 08/12/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | 02/26/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | 01/17/1986SE |
| K853276 | Aso Slide EikenGTQ · Traditional | 08/20/1985SE |
| K843760 | Uropaper Eiken GJIL · Traditional | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | 12/18/1984SE |
| K843755 | Uropaper Eiken 6BJIL · Traditional | 12/18/1984SE |
Questions and answers
When was Slide Culture U 'Eiken' cleared by the FDA?
Slide Culture U 'Eiken' (K861631) received a 510(k) decision of Substantially Equivalent on June 10, 1986, 42 days after the submission was received.
What is the product code of K861631?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.