The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Synthesis--addition Of Bilirubin As A Measured Parameter For Neonate Whole Blood Samples.
| Device ID | K980646 |
| 510k Number | K980646 |
| Device Name: | IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-19 |
| Decision Date | 1998-05-06 |
| Summary: | summary |