Culturia Macconkey-Mug
FDA 510(k) K934759 · Clinical Convenience Products, Inc.
510(k) numberK934759
Submission
- Device name
- Culturia Macconkey-Mug
- Applicant
- Clinical Convenience Products, Inc.
Madison, WI, US - Received
- October 4, 1993
- Decision date
- September 9, 1994
- 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 |
| K924218 | Bac-T-ScreenJXA · Traditional | Biomerieux Vitek, Inc. | 02/03/1993SE |
| K921045 | Diaslide Urine Culturing DeviceJXA · Traditional | Savyon Diagnostics , Ltd. | 09/28/1992SE |
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | Culture Kits, Inc. | 10/04/1991SE |
More from Culture Kits, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870502 | Culturia Macconkey-Mug/Modified Tsa SystemsJSI · Traditional | 02/26/1987SE |
| K864764 | Culturia Macconkey-Mug/Cled SystemsJSI · Traditional | 12/29/1986SE |
| K800215 | Culturia Macconkey/Cled #DM87JXA · Traditional | 02/13/1980SE |
| K792579 | Culturia Macconkey/Columbia CnaJXA · Traditional | 01/11/1980SE |
| K792284 | Culturia Emb/Columbia Cna W/5% SheepJXA · Traditional | 12/19/1979SE |
Questions and answers
When was Culturia Macconkey-Mug cleared by the FDA?
Culturia Macconkey-Mug (K934759) received a 510(k) decision of Substantially Equivalent on September 9, 1994, 340 days after the submission was received.
What is the product code of K934759?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.