FDA Product Code
FDA Product Code JIA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1310
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | 2019-11-06 | Traditional | PDF ↗ |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 | Traditional | PDF ↗ |
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2013-06-20 | Traditional | PDF ↗ |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Wallac OY | 2008-08-07 | Traditional | PDF ↗ |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | 1999-06-21 | Traditional | PDF ↗ |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | 1999-06-21 | Traditional | PDF ↗ |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | 1999-06-16 | Traditional | PDF ↗ |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Isolab, Inc. | 1996-02-01 | Traditional | PDF ↗ |
| K951329 | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | 1995-11-09 | Traditional | PDF ↗ |
Product code JIA · Class I · Clinical Chemistry. Data: openFDA.