510(k) K013819
- Device
- URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
- Applicant
- SIERRA DIAGNOSTIC, L.L.C.
- 510(k) number
- K013819
- Product code
- JTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-28
- Date received
- 2001-11-16
- Regulation
- 866.2900
- Classification name
- System, Transport, Aerobic
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD R STONE
- Address
- 1800 Massachusetts Ave. NW Suite 200 Washington DC US 20036 20036
FDA Registration Numbers#
- 3013557562
- 3011689956
- 3016587486
- 3010131578
- 2649614
- 3002806470
- 3010407203
- 3015441043
- 3010132111
- 3013517171
- 9681465
- 1924669
- 3011088743
- 2243072
- 9610126
- 3043226252
- 1420054
- 3002444944
- 1423395
- 1220477
- 3010155648
- 3012494290
- 1917413
- 8021914
- 1216735
Source Documents#
Other 510(k) Records For Product Code JTW #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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