Product code JSL
- Device name
- Culture Media, Anaerobic Transport
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2390
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | Copan Italia Spa | 1997-08-20 |
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | Copan Italia Spa | 1997-08-20 |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1995-02-16 |
| K925450 | BIONOR TRANSPORTMEDIUM | Skoug Research Corp. | 1993-06-25 |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Anaerobe Systems | 1984-04-04 |
| K834357 | ANA TRANS TUBE & SWABS STERILE PACK | Anaerobe Systems | 1984-01-31 |
| K770840 | PRE-REDUCED ANAEROBIC MEDIA | Gibco Laboratories Life Technologies, Inc. | 1977-06-08 |
| K770650 | PRE-DUCED CULTURE MEDIA | Gibco Laboratories Life Technologies, Inc. | 1977-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 38053326002077 | CultureSwab™ MaxV(+) | COPAN ITALIA SPA | 2023-06-14 |
| 38053326001919 | BD BBL ™ CultureSWAB ™ | COPAN ITALIA SPA | 2023-03-03 |
| 38053326009823 | Transystem™ | COPAN ITALIA SPA | 2023-03-03 |
| 38053326001926 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000595 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008895 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008871 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008802 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008796 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008765 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008758 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008741 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008734 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008727 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 38053326008710 | TransPorter® | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000601 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |
| 38053326002060 | CultureSwab™ MaxV(+) | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000861 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000588 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001902 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001896 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001865 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001858 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001841 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001834 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001827 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 38053326001605 | BBL™ CultureSwab™ Plus | COPAN ITALIA SPA | 2022-12-07 |
| 28053326004913 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326001578 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326001219 | Transystem™ | COPAN ITALIA SPA | 2022-12-07 |