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InSure FIT
ENTERIX INC. · Model 01 · UDI-DI 00850093003033
1
510(k) clearances
1
Adverse events
0
Recalls
11
Facilities
Description
InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each)
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.