Atlas FDA

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

FDA 510(k) clearance K101089 · decided 2011-07-13

Clearance details

K-number
K101089
Device name
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
Applicant
Medica Corp.
Decision
Substantially Equivalent
Date received
2010-04-19
Decision date
2011-07-13
Days to decision
450 days
Clearance type
Traditional
Product code
DCF
Device class
2
Regulation number
866.5040
Medical specialty
Immunology
Advisory committee
Immunology
Location
Bedford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.