The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Iron-pc-sl Assay Model # 151-10, 151-26.
| Device ID | K020816 |
| 510k Number | K020816 |
| Device Name: | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Contact | Nancy Olscamp |
| Correspondent | Nancy Olscamp DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, 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 | 2002-03-13 |
| Decision Date | 2002-05-14 |