The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Dclare Immunodip Stickfor Microalbuminuria.
| Device ID | K972337 |
| 510k Number | K972337 |
| Device Name: | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| 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 | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-23 |
| Decision Date | 1997-08-08 |