The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Total Protein (micro) Assay, Catalogue Number 450-50.
| Device ID | K973108 |
| 510k Number | K973108 |
| Device Name: | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 |
| Classification | Biuret (colorimetric), Total Protein |
| 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 | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-19 |
| Decision Date | 1998-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400805 | K973108 | 000 |