The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Glucose-sl-c Assay, Model 257-30.
| Device ID | K023739 |
| 510k Number | K023739 |
| Device Name: | GLUCOSE-SL-C ASSAY, MODEL 257-30 |
| Classification | Hexokinase, Glucose |
| 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 | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-07 |
| Decision Date | 2003-01-17 |