The following data is part of a premarket notification filed by Porton Cambridge Ltd. with the FDA for Quantase Phenylalanine Assay.
Device ID | K922547 |
510k Number | K922547 |
Device Name: | QUANTASE PHENYLALANINE ASSAY |
Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
Applicant | PORTON CAMBRIDGE LTD. LANWADES BUSINESS PARK KENNETT, NEWMARKET CB8 7PW, UNITED KINGDOM, GB |
Contact | DR. G SHEPPARD |
Correspondent | DR. G SHEPPARD PORTON CAMBRIDGE LTD. LANWADES BUSINESS PARK KENNETT, NEWMARKET CB8 7PW, UNITED KINGDOM, GB |
Product Code | JNB |
CFR Regulation Number | 862.1555 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-01 |
Decision Date | 1994-10-13 |