Product code LXG
- Device name
- Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2050
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021927 | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM | Biomet, Inc. | 2002-07-12 |
| K943466 | MINI S.F.T. (URINE PRESERVATIVE) | Cambridge Diagnostic Products, Inc. | 1995-05-24 |
| K896802 | MAGNET PAD | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590812478 | DxU | Beckman Coulter, Inc. | 2026-06-24 |
| 08435389828150 | SAMPLE PREPARATION KIT | BIOTECHNOLOGY INSTITUTE SL | 2026-05-27 |
| 09120123910022 | Anchor Tips, 300uL | STRATEC Consumables GmbH | 2026-01-14 |
| 10849832025815 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-07-23 |
| 10849832024238 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-07-20 |
| 10849832024276 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-07-20 |
| 10849832027055 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2025-07-20 |
| 04038917988278 | Archiving Cap with filter | Sarstedt Aktiengesellschaft & Co.KG | 2024-02-20 |
| 10385480634127 | Nova | NOVA BIOMEDICAL CORPORATION | 2022-12-07 |
| H10869293 | Corning | Corning Incorporated | 2022-05-19 |
| H10869433 | Corning | Corning Incorporated | 2022-05-19 |
| H10869333 | Corning | Corning Incorporated | 2022-05-19 |
| H10869323 | Corning | Corning Incorporated | 2022-05-19 |
| H10869313 | Corning | Corning Incorporated | 2022-05-19 |
| H10869283 | Corning | Corning Incorporated | 2022-05-19 |
| H10869263 | Corning | Corning Incorporated | 2022-05-19 |
| H10869253 | Corning | Corning Incorporated | 2022-05-19 |
| H10869243 | Corning | Corning Incorporated | 2022-05-19 |
| H10869223 | Corning | Corning Incorporated | 2022-05-19 |
| H10869203 | Corning | Corning Incorporated | 2022-05-19 |
| H10869183 | Corning | Corning Incorporated | 2022-05-19 |
| H10869173 | Corning | Corning Incorporated | 2022-05-19 |
| 10810050244234 | NA | DOMICO MED-DEVICE, LLC | 2021-04-28 |
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| M52512720 | QuickGel IFE Applicator Blades | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52514730 | Siliconized Cuvettes for AggRAM & PACKS-4 | HELENA LABORATORIES CORPORATION | 2017-03-17 |