Product code JIA
- Device name
- Enzymatic Methods, Galactose
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1310
- Review panel
- CH
- 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 |
|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019-11-06 |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 |
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2013-06-20 |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Wallac OY | 2008-08-07 |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | 1999-06-21 |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 1999-06-21 |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | 1999-06-16 |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Isolab, Inc. | 1996-02-01 |
| K951329 | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | 1995-11-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817830023099 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00817830023105 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00817830023112 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00817830023129 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00840239014863 | Galactose (with Membrane Plate) ELISA | DRG International Inc | 2021-06-07 |
| 00840239014870 | Galactose (without Membrane Plate) ELISA | DRG International Inc | 2021-06-07 |
| 00840239014887 | Galactose (with Membrane Plate) ELISA | DRG International Inc | 2021-06-07 |
| 00840239014894 | Galactose (without Membrane Plate) ELISA | DRG International Inc | 2021-06-07 |
| 06438147367917 | GSP Neonatal Total Galactose kit | Wallac Oy | 2021-06-04 |
| 00725609000595 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2020-12-17 |
| 06438147275281 | Neonatal Total Galactose kit | Wallac Oy | 2017-05-02 |
| 06438147328031 | GSP Neonatal Total Galactose Kit | Wallac Oy | 2017-05-02 |
| 00725609000090 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2016-10-14 |
| 00725609000106 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2016-10-14 |
| 00725609000199 | Accuwell | ASTORIA-PACIFIC, INC. | 2016-10-14 |