Atlas FDA

EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT

FDA 510(k) clearance K101088 · decided 2011-04-04

Clearance details

K-number
K101088
Device name
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
Applicant
Medica Corp.
Decision
Substantially Equivalent
Date received
2010-04-19
Decision date
2011-04-04
Days to decision
350 days
Clearance type
Traditional
Product code
CIX
Device class
2
Regulation number
862.1035
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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.