JIA — Enzymatic Methods, Galactose Class I
FDA Device Classification
Classification Details
- Product Code
- JIA
- Device Class
- Class I
- Regulation Number
- 862.1310
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K190335 | perkinelmer | GSP Neonatal Total Galactose kit | November 6, 2019 |
| K133652 | wallac oy, a subsidiary of perkinelmer | GSP NEONATAL TOTAL GALACTOSE KIT | April 28, 2014 |
| K121101 | astoria-pacific | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | June 20, 2013 |
| K071649 | wallac | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND | August 7, 2008 |
| K990644 | quantase | QUANTASE TOTAL GALACTOSE SCREENING ASSAY | June 21, 1999 |
| K990654 | quantase | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT | June 21, 1999 |
| K991498 | neometrics | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | June 16, 1999 |
| K950481 | isolab | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | February 1, 1996 |
| K951329 | icn pharmaceuticals | IMMUCHEM GAL-MW EA | November 9, 1995 |