The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 4000 With Iqm (addition Of Total Bilirubin Parameter), Gem Cvp 2 (addition Of Total Bilirubim Assignment To.
| Device ID | K093623 |
| 510k Number | K093623 |
| Device Name: | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL AVE. Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL AVE. Bedford, MA 01730 |
| Product Code | CIG |
| Subsequent Product Code | GLK |
| Subsequent Product Code | JJY |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950573685 | K093623 | 000 |
| 08426950573678 | K093623 | 000 |
| 08426950573661 | K093623 | 000 |
| 08426950573654 | K093623 | 000 |
| 08426950573647 | K093623 | 000 |
| 08426950573630 | K093623 | 000 |
| 08426950947370 | K093623 | 000 |
| 08426950452591 | K093623 | 000 |