The following data is part of a premarket notification filed by Quantase Ltd. with the FDA for Quantase Total Galactose Screening Assay 500 Test Kit.
| Device ID | K990654 |
| 510k Number | K990654 |
| Device Name: | QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT |
| Classification | Enzymatic Methods, Galactose |
| Applicant | QUANTASE LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD Perth, Scotland, GB Ph2 8df |
| Contact | R. Stewart Campbell |
| Correspondent | R. Stewart Campbell QUANTASE LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD Perth, Scotland, GB Ph2 8df |
| Product Code | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-06-21 |