FDA-Device2013-12-25Class II
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Instrumentation Laboratory Co.
Hazard
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Sold states
Nationwide Distribution
Affected count
6504 kits
Manufactured in
180 Hartwell Road, N/A, Bedford, MA, United States
Products
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0515-2014Don't want to check this manually?
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