Enzymatic Methods, Galactose
Enzymatic Methods for Galactose is a clinical chemistry test system using enzymatic reactions to measure galactose concentration in blood or urine, used in the screening and monitoring of galactosemia and related inborn errors of carbohydrate metabolism. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JIA, regulated under 21 CFR 862.1310, within the Clinical Chemistry medical specialty. This device is eligible for third-party review where applicable.
Research product code JIA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JIA
- Device Class
- FDA class 1
- Regulation Number
- 862.1310
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kit | Nov 06, 2019 | Substantially Equivalent | Perkinelmer, Inc. |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | Apr 28, 2014 | Substantially Equivalent | Wallac Oy, A Subsidiary of Perkinelmer, Inc. |
| K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | Jun 20, 2013 | Substantially Equivalent | Astoria-Pacific, Inc. |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | Aug 07, 2008 | Substantially Equivalent | Wallac OY |
| K990654 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | Jun 21, 1999 | Substantially Equivalent | Quantase , Ltd. |
| K990644 | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | Jun 21, 1999 | Substantially Equivalent | Quantase , Ltd. |
| K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | Jun 16, 1999 | Substantially Equivalent | Neometrics, Inc. |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | Feb 01, 1996 | Substantially Equivalent | Isolab, Inc. |
| K951329 | IMMUCHEM GAL-MW EA | Nov 09, 1995 | Substantially Equivalent | Icn Pharmaceuticals, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.