HEMOSIL HOMOCYSTEINE AND CONTROLS— 510(k) K061598
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K061598 for HEMOSIL HOMOCYSTEINE AND CONTROLS, Substantially Equivalent on 2006-09-22. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code LPS
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- K113793 — HOMOCYSTEINE TEST
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
More clearances from Instrumentation Laboratory CO
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