The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Creatinine-s Assay.
| Device ID | K934587 |
| 510k Number | K934587 |
| Device Name: | CREATININE-S ASSAY |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck, R.t., B.sc. |
| Correspondent | Karen Callbeck, R.t., B.sc. DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-23 |
| Decision Date | 1994-03-11 |