K980646 is an FDA 510(k) clearance for the IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES. This device is classified as a Bilirubin (total And Unbound) In The Neonate Test System (Class I - General Controls, product code MQM).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 6, 1998, 76 days after receiving the submission on February 19, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1113.
| 510(k) Number | K980646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1998 |
| Decision Date | May 06, 1998 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MQM — Bilirubin (total And Unbound) In The Neonate Test System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1113 |