JIA · Enzymatic Methods, Galactose
Clinical Chemistry · 21 CFR 862.1310 · Class 1
Overview
| Product Code | JIA |
|---|---|
| Device Name | Enzymatic Methods, Galactose |
| Regulation | 21 CFR 862.1310 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.
Classification Rationale
Class I.
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Perkinelmer, Inc. | Nov 6, 2019 | SESE |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | Apr 28, 2014 | SESE |
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Jun 20, 2013 | SESE |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Wallac OY | Aug 7, 2008 | SESE |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | Jun 21, 1999 | SESE |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Quantase , Ltd. | Jun 21, 1999 | SESE |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Neometrics, Inc. | Jun 16, 1999 | SESE |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Isolab, Inc. | Feb 1, 1996 | SESE |
| K951329 | IMMUCHEM GAL-MW EA | Icn Pharmaceuticals, Inc. | Nov 9, 1995 | SESE |
Top Applicants
- Quantase , Ltd. — 2 clearances
- Wallac Oy, A Subsidiary of Perkinelmer, Inc. — 1 clearance
- Wallac OY — 1 clearance
- Perkinelmer, Inc. — 1 clearance
- Neometrics, Inc. — 1 clearance
