The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Enzymatic Creatinine Assay (265 Series).
| Device ID | K070383 |
| 510k Number | K070383 |
| Device Name: | ENZYMATIC CREATININE ASSAY (265 SERIES) |
| Classification | Enzymatic Method, Creatinine |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Debbie M Murray |
| Correspondent | Debbie M Murray DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-09 |
| Decision Date | 2007-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400423 | K070383 | 000 |
| 00628063400393 | K070383 | 000 |