Bionor Transportmedium
FDA 510(k) K925450 · Skoug Research Corp.
510(k) numberK925450
Submission
- Device name
- Bionor Transportmedium
- Applicant
- Skoug Research Corp.
Cambridge, MA, US - Received
- October 28, 1992
- Decision date
- June 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K944847 | Kultsure/Starswab Anaerobic Transport SystemJSL · Traditional | Starplex Scientific, Inc. | 02/16/1995SE |
| 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 |
Questions and answers
When was Bionor Transportmedium cleared by the FDA?
Bionor Transportmedium (K925450) received a 510(k) decision of Substantially Equivalent on June 25, 1993, 240 days after the submission was received.
What is the product code of K925450?
The FDA product code is JSL – Culture Media, Anaerobic Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.