The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Serum Iron-sl Assay, Catalogue Numbers 157-10, 157-30.
| Device ID | K973933 |
| 510k Number | K973933 |
| Device Name: | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 |
| Classification | Photometric Method, Iron (non-heme) |
| 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 | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1997-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400645 | K973933 | 000 |
| 00628063400232 | K973933 | 000 |