The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Bilirubin-sl (direct) Assay Catalogue Number 247-10,247-30.
| Device ID | K981609 |
| 510k Number | K981609 |
| Device Name: | BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, P.e.i., CA C1e1b0 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, P.e.i., CA C1e1b0 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-05 |
| Decision Date | 1998-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400560 | K981609 | 000 |
| 00628063400164 | K981609 | 000 |