The following data is part of a premarket notification filed by Quantase Ltd. with the FDA for Quantase Phe/gal Screening Assay.
| Device ID | K984463 |
| 510k Number | K984463 |
| Device Name: | QUANTASE PHE/GAL SCREENING ASSAY |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| 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 | JNB |
| Subsequent Product Code | JIA |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-16 |
| Decision Date | 1999-02-16 |