Diaslide Urine Culturing Device
FDA 510(k) K921045 · Savyon Diagnostics , Ltd.
510(k) numberK921045
Submission
- Device name
- Diaslide Urine Culturing Device
- Applicant
- Savyon Diagnostics , Ltd.
Ashdod, IL - Received
- March 4, 1992
- Decision date
- September 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | Culture Kits, Inc. | 10/04/1991SE |
More from Culture Kits, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914327 | Seroelisa(Tm) Chlamydia Iga Test KitLJC · Traditional | 06/09/1992SE |
| K915281 | Serolisa Chlamydia Igg Test KitLJC · Traditional | 03/23/1992SE |
| K910644 | Ipazyme (TM) Chlamydia Igg-IgaLKH · Traditional | 03/19/1991SE |
| K901975 | Ipazyme(Tm) Chlamydia True Igm(Tm)LKH · Traditional | 03/08/1991SE |
Questions and answers
When was Diaslide Urine Culturing Device cleared by the FDA?
Diaslide Urine Culturing Device (K921045) received a 510(k) decision of Substantially Equivalent on September 28, 1992, 208 days after the submission was received.
What is the product code of K921045?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.