The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Alkaline Phosphatase-sl Assay, Models 328-17 And 328-30.
| Device ID | K003093 |
| 510k Number | K003093 |
| Device Name: | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063401192 | K003093 | 000 |
| 00628063400096 | K003093 | 000 |
| 00628063400089 | K003093 | 000 |