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 |