The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Iron (total) Assay Catalogue No. 102-10, 102-25.
| Device ID | K961587 |
| 510k Number | K961587 |
| Device Name: | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400638 | K961587 | 000 |
| 00628063400621 | K961587 | 000 |