The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Dcl Microalbumin Assay, Model 252-20.
| Device ID | K051191 |
| 510k Number | K051191 |
| Device Name: | DCL MICROALBUMIN ASSAY, MODEL 252-20 |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Penny White |
| Correspondent | Penny White DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-10 |
| Decision Date | 2005-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400812 | K051191 | 000 |
| 00628063401116 | K051191 | 000 |