The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Bilirubin-sl (total) Assay, Model 284-10/30.
| Device ID | K023330 |
| 510k Number | K023330 |
| Device Name: | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-04 |
| Decision Date | 2002-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400225 | K023330 | 000 |
| 00628063400201 | K023330 | 000 |
| 00628063400195 | K023330 | 000 |