Mini-Tip Culturette
FDA 510(k) K803298 · Marion Laboratories, Inc.
510(k) numberK803298
Submission
- Device name
- Mini-Tip Culturette
- Applicant
- Marion Laboratories, Inc.
Walker, MI, US - Received
- December 30, 1980
- Decision date
- January 12, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTW – System, Transport, Aerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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|---|---|---|---|
| K121039 | Copan Mswab Collection, Transport and Preservation SystemJTW · Traditional | Copan Flock Technologies | 05/25/2012SE |
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 06/23/2006SE |
| K022874 | Gen-Probe Aptima Combo 2 AssayJTW · Traditional | Gen-Probe, Inc. | 09/17/2002SE |
| K013819 | Urine Collection, Preservation and Transport SystemJTW · Traditional | Sierra Diagnostic, LLC | 02/28/2002SE |
| K993161 | Copan Easy-Swab Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 11/09/1999SE |
| K983244 | Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)JTW · Traditional | Trek Diagnostic Systems, Inc. | 11/30/1998SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | Difco Laboratories, Inc. | 04/26/1996SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | Difco Laboratories, Inc. | 02/22/1994SE |
| K904773 | P and T MediumJTW · Traditional | Gibson Laboratories, Inc. | 12/04/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | Fairleigh Dickinson Laboratories, Inc. | 10/24/1989SE |
More from Fairleigh Dickinson Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Mini-Tip Culturette cleared by the FDA?
Mini-Tip Culturette (K803298) received a 510(k) decision of Substantially Equivalent on January 12, 1981, 13 days after the submission was received.
What is the product code of K803298?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.