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 |