The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Unsaturated Iron Binding Capacity (uibc) Assay.
| Device ID | K963116 |
| 510k Number | K963116 |
| Device Name: | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400959 | K963116 | 000 |
| 00628063400942 | K963116 | 000 |
| 00628063400935 | K963116 | 000 |
| 00628063400928 | K963116 | 000 |