COLOR-MONOGEN— 510(k) K012901
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K012901 for COLOR-MONOGEN, Substantially Equivalent on 2001-09-27. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code KTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5640
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code KTN
view allMore clearances from Instrumentation Laboratory CO
view allData sourced from openFDA. This site is unofficial and independent of the FDA.