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 |