Panels › Clinical Chemistry › Product code JIA · Class 1
Enzymatic Methods, Galactose
Regulation 862.1310
0510(k)s in 12 months (9 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in JIA
| Company | 510(k)s | Recalls |
|---|---|---|
| PerkinElmer Life Sciences Inc | 0 | 3 |
| Perkin Elmer Life and Analytical Sciences Inc | 0 | 2 |
| Quantase , Ltd. | 2 | 0 |
| Astoria-Pacific, Inc. | 1 | 0 |
| Icn Pharmaceuticals, Inc. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Neometrics, Inc. | 1 | 0 |
| Perkinelmer, Inc. | 1 | 0 |
| PerkinElmer LAS Inc | 0 | 1 |
| Wallac OY | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2019 | K190335 | GSP Neonatal Total Galactose kit Perkinelmer, Inc. | JIA |
| Apr 28, 2014 | K133652 | GSP NEONATAL TOTAL GALACTOSE KIT Wallac Oy, A Subsidiary of Perkinelmer, Inc. | JIA |
| Jun 20, 2013 | K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT Astoria-Pacific, Inc. | JIA |
| Aug 7, 2008 | K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B Wallac OY | JIA |
| Jun 21, 1999 | K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT Quantase , Ltd., GB | JIA |
| Jun 21, 1999 | K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY Quantase , Ltd., GB | JIA |
| Jun 16, 1999 | K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL Neometrics, Inc. | JIA |
| Feb 1, 1996 | K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT Isolab, Inc. | JIA |
| Nov 9, 1995 | K951329 | IMMUCHEM GAL-MW EA Icn Pharmaceuticals, Inc. | JIA |
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