Tri-Techin. Custom Blood And/Or Urine Transport Kit
FDA 510(k) K952246 · Tri-Tech, Inc.
510(k) numberK952246
Submission
- Device name
- Tri-Techin. Custom Blood And/Or Urine Transport Kit
- Applicant
- Tri-Tech, Inc.
Southport, NC, US - Received
- May 12, 1995
- Decision date
- June 20, 1995
- 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 |
| 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 |
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | Culture Kits, Inc. | 10/04/1991SE |
More from Culture Kits, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971111 | Tri-Tech Inc., Evacuated Blood Collection Tube, Gray StopperJKA · Traditional | 06/16/1997SE |
| K922343 | Tri-Tech Inc. Custom Sexual Assault KitJKA · Traditional | 02/17/1994SESK |
| K922342 | Tri-Tech Inc. Custom Blood AlcoholJKA · Traditional | 08/27/1993SEKD |
| K912140 | Stairmaster Model 6000 ErgometerISD · Traditional | 12/17/1991SE |
| K912058 | Gauntlet Stair ClimberISD · Traditional | 10/24/1991SE |
| K912057 | 4000 PT Exercise SystemISD · Traditional | 10/24/1991SE |
| K912056 | Gravitron Upper Body System ExerciserISD · Traditional | 10/24/1991SE |
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | 09/17/1990SE |
| K843839 | Stat/Pb ReagentDOF · Traditional | 01/03/1985SE |
| K813075 | Tritec Doc TMBZD · Traditional | 12/09/1981SE |
Questions and answers
When was Tri-Techin. Custom Blood And/Or Urine Transport Kit cleared by the FDA?
Tri-Techin. Custom Blood And/Or Urine Transport Kit (K952246) received a 510(k) decision of Substantially Equivalent on June 20, 1995, 39 days after the submission was received.
What is the product code of K952246?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.