Product code LQM
- Device name
- Gram Negative Identification Panel
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923313 | ROCHE OXI/FERM II | Roche Diagnostic Systems, Inc. | 1993-04-05 |
| K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | Biomerieux Vitek, Inc. | 1993-03-23 |
| K912897 | SCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-28 |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | Vitek Systems, Inc. | 1991-06-24 |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | Radiometer America, Inc. | 1989-06-09 |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | 1986-09-11 |
| K851528 | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM | Pasco Laboratories, Inc. | 1985-07-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590798987 | MicroScan | Beckman Coulter, Inc. | 2025-12-08 |
| 15099590798994 | MicroScan | Beckman Coulter, Inc. | 2025-12-08 |
| 15099590799007 | MicroScan | Beckman Coulter, Inc. | 2025-12-08 |
| 00848838074325 | PLATE DRY CLI GRAM+ ID AUTO | REMEL, INC. | 2023-06-20 |
| 05032384127917 | MICROBACT REAGENT SET D | OXOID LIMITED | 2022-12-07 |
| 15099590657604 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 15099590657321 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 15099590657239 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 15099590655402 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 05032384127955 | MICROBACT GNB 24E TRAY (40 ID'S) | OXOID LIMITED | 2022-12-04 |
| 05032384127962 | MICROBACT GNB 12A STRIP (60 ID'S) | OXOID LIMITED | 2022-12-04 |
| 05032384127979 | MICROBACT GNB 12B STRIP (60 ID'S) | OXOID LIMITED | 2022-12-04 |
| 15099590655181 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655198 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655204 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655211 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655228 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655235 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655242 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590655259 | MicroScan | Beckman Coulter, Inc. | 2022-11-15 |
| 15099590765385 | MicroScan | Beckman Coulter, Inc. | 2022-08-01 |
| 15099590765378 | MicroScan | Beckman Coulter, Inc. | 2022-08-01 |
| 15099590765361 | MicroScan | Beckman Coulter, Inc. | 2022-08-01 |
| 03573026529987 | VITEK® 2 GN | BIOMERIEUX , INC. | 2020-06-02 |
| 00382904480073 | BD Phoenix™ NID | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| M578GPID2 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2016-09-24 |
| 15099590657680 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590658038 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590658021 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590657987 | MicroScan | Beckman Coulter, Inc. | 2016-08-24 |