The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Uric Acid Cataloge# 220-93/94/97.
| Device ID | K955496 |
| 510k Number | K955496 |
| Device Name: | URIC ACID CATALOGE# 220-93/94/97 |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-02-23 |