IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES— 510(k) K980646
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K980646 for IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES, Substantially Equivalent on 1998-05-06. Applicant: Instrumentation Laboratory CO. Device class: 1.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code MQM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1113
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code MQM
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