JIA
9 FDA 510(k) clearances · Product code
231 daysmedian time to decision
435 days90th percentile
9clearances measured
FDA profile
- Official device name
- Enzymatic Methods, Galactose
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1310
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GSP Neonatal Total Galactose kit (K190335) | Perkinelmer, Inc. | 2019-11-06 |
| GSP NEONATAL TOTAL GALACTOSE KIT (K133652) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2014-04-28 |
| SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (K121101) | Astoria-Pacific, Inc. | 2013-06-20 |
| NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B (K071649) | Wallac OY | 2008-08-07 |
| QUANTASE TOTAL GALACTOSE SCREENING ASSAY (K990644) | Quantase , Ltd. | 1999-06-21 |
| QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (K990654) | Quantase , Ltd. | 1999-06-21 |
| ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (K991498) | Neometrics, Inc. | 1999-06-16 |
| NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (K950481) | Isolab, Inc. | 1996-02-01 |
| IMMUCHEM GAL-MW EA (K951329) | Icn Pharmaceuticals, Inc. | 1995-11-09 |
Track JIA automatically
Every clearance here is in the API, with alerts when new ones post.