Kultsure/Starswab Anaerobic Transport System
FDA 510(k) K944847 · Starplex Scientific, Inc.
510(k) numberK944847
Submission
- Device name
- Kultsure/Starswab Anaerobic Transport System
- Applicant
- Starplex Scientific, Inc.
Etobicoke, Ontario, CA - Received
- September 30, 1994
- Decision date
- February 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JSL – Culture Media, Anaerobic Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972449 | Copan Venturi Transystem Amies Medium with CharcoalJSL · Traditional | Copan Italia Spa | 08/20/1997SE |
| K972448 | Copan Venturi Transystem Amies Medium Without CharcoalJSL · Traditional | Copan Italia Spa | 08/20/1997SE |
| K925450 | Bionor TransportmediumJSL · Traditional | Skoug Research Corp. | 06/25/1993SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | Anaerobe Systems | 04/04/1984SE |
| K834357 | Ana Trans Tube & Swabs Sterile PackJSL · Traditional | Anaerobe Systems | 01/31/1984SE |
| K770840 | Pre-Reduced Anaerobic MediaJSL · Traditional | Gibco Laboratories Life Technologies, Inc. | 06/08/1977SE |
| K770650 | Pre-Duced Culture MediaJSL · Traditional | Gibco Laboratories Life Technologies, Inc. | 04/15/1977SE |
More from Gibco Laboratories Life Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032246 | Modification to Multitrans Culture Collection and Transport SystemJSM · Special | 08/13/2003SE |
| K022388 | Startox Drug of Abuse Screening Test (4)DJC · Traditional | 02/27/2003SE |
| K021006 | Startox Drug of Abuse Screening TestDKZ · Traditional | 06/10/2002SE |
| K962843 | Multitrans Culture Collection and Transport SystemJSM · Traditional | 09/18/1996SE |
| K960997 | Starswab Culture Collection and Transport SystemLIO · Traditional | 04/03/1996SE |
| K924364 | Vacuplus Tubes with Grey StoppersJKA · Traditional | 03/01/1993SE |
| K924362 | Vacuplus Tubes with Lavander StoppersJKA · Traditional | 03/01/1993SE |
| K924361 | Vacuplus Tubes with Green StoppersJKA · Traditional | 03/01/1993SE |
| K924363 | Vacuplus(R) Star-Sep(Tm)JKA · Traditional | 02/08/1993SE |
| K924365 | Vacuplus Tubes with Brick Red StoppersJKA · Traditional | 12/28/1992SE |
Questions and answers
When was Kultsure/Starswab Anaerobic Transport System cleared by the FDA?
Kultsure/Starswab Anaerobic Transport System (K944847) received a 510(k) decision of Substantially Equivalent on February 16, 1995, 139 days after the submission was received.
What is the product code of K944847?
The FDA product code is JSL – Culture Media, Anaerobic Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.