The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Creatinine-s Assay, Model 221-30, 221-50, 221-17.
| Device ID | K000055 |
| 510k Number | K000055 |
| Device Name: | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, CA C1e 2a6 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-07 |
| Decision Date | 2000-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400416 | K000055 | 000 |
| 00628063400409 | K000055 | 000 |