The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Y-glutamyltransferase-sl Assay , Cataloge Number 324-10, 324-30.
| Device ID | K974000 |
| 510k Number | K974000 |
| Device Name: | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1997-11-04 |