The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Quantase Phenylalanine Assay.
| Device ID | K961515 |
| 510k Number | K961515 |
| Device Name: | QUANTASE PHENYLALANINE ASSAY |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | Eileen Mccafferty |
| Correspondent | Eileen Mccafferty SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-10 |
| Decision Date | 1996-06-12 |