Product code JTW
- Device name
- System, Transport, Aerobic
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2900
- 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 |
|---|---|---|---|
| K121039 | COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | Copan Flock Technologies | 2012-05-25 |
| K061301 | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | Copan Diagnostics, Inc. | 2006-06-23 |
| K022874 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2002-09-17 |
| K013819 | URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM | Sierra Diagnostic, LLC | 2002-02-28 |
| K993161 | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | Copan Diagnostics, Inc. | 1999-11-09 |
| K983244 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) | Trek Diagnostic Systems, Inc. | 1998-11-30 |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Difco Laboratories, Inc. | 1996-04-26 |
| K934894 | CULTURESWAB TRANSPORT SYSTEM | Difco Laboratories, Inc. | 1994-02-22 |
| K904773 | P AND T MEDIUM | Gibson Laboratories, Inc. | 1990-12-04 |
| K895187 | FDL, INC.'S TRANSPORT SYSTEM | Fairleigh Dickinson Laboratories, Inc. | 1989-10-24 |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Precision Dynamics Corp. | 1988-07-08 |
| K872325 | GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT | Technology Management & Marketing, Inc. | 1987-08-12 |
| K872326 | GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT | Technology Management & Marketing, Inc. | 1987-08-11 |
| K843359 | URINE TRANSPORT KIT | Applied Polytechnology, Inc. | 1984-09-27 |
| K843341 | GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-09-27 |
| K843173 | CELL-MATICS VIRAL TRANSPORT PACK | Difco Laboratories, Inc. | 1984-09-06 |
| K840719 | BAKTERIETTE-VI-PAK | Great Lakes Intl. | 1984-04-04 |
| K840968 | PRESERV TRANSPORT & CULTURE PACK | Preventive Diagnostics Corp. | 1984-03-23 |
| K840990 | PRESERV CARY BLAIR TRANSPORT PACK | Preventive Diagnostics Corp. | 1984-03-23 |
| K840991 | PRESERV BUFFERED GLYCEROL SALINE | Preventive Diagnostics Corp. | 1984-03-23 |
| K831579 | GONORRHEA TRANSETTE 1 & 3 | Spectrum Diagnostic, Inc. | 1983-06-17 |
| K830250 | CVT VIRAL TRANSPORTS | Immulok, Inc. | 1983-02-28 |
| K823443 | HERPES TRANSETTE | Spectrum Diagnostic, Inc. | 1982-12-03 |
| K811283 | JEMBEC TRANSPORT SYSTEM | Biolog, Inc. | 1981-06-12 |
| K811284 | GC TTANSPORT SYSTEM | Biolog, Inc. | 1981-06-12 |
| K803298 | MINI-TIP CULTURETTE | Marion Laboratories, Inc. | 1981-01-12 |
| K802563 | TRANSETTE SYSTEM/COLLECTION & TRANSP | Inolex Corp./Div of Biomedical | 1980-10-31 |
| K802023 | CULSWAB CAT.#978 & 979 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K791953 | PDC 304 DOUBLE SWAB CULTURE COLLECTION | Precision Dynamics Corp. | 1979-10-30 |
| K791924 | PDC 104 SINGLE SWAB CULTURE COLLECTION | Precision Dynamics Corp. | 1979-10-17 |
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| 50382903649759 | BD Vacutainer® Urine Collection Cups | BECTON, DICKINSON AND COMPANY | 2024-04-05 |
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| 28053326000236 | eSwab™ | COPAN ITALIA SPA | 2023-06-14 |
| 38053326009526 | eSwab™ | COPAN ITALIA SPA | 2023-05-11 |
| 50382903649667 | BD Vacutainer® Urine Transfer Straw | BECTON, DICKINSON AND COMPANY | 2023-03-15 |
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| 38053326000059 | eSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326002643 | eSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000199 | eSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000168 | eSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000144 | eSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000021 | eSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 50382903649469 | BD Vacutainer® Urinalysis Cup Kit | BECTON, DICKINSON AND COMPANY | 2020-11-16 |
| 50382903649810 | BD Vacutainer® Urinalysis Cup Kit | BECTON, DICKINSON AND COMPANY | 2020-11-16 |
| 50382903649896 | BD Vacutainer® Urinalysis Cup Kit | BECTON, DICKINSON AND COMPANY | 2020-11-16 |