DeviceClearance

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH— 510(k) K060452

Substantially Equivalent

Neo-Genesis

FDA 510(k) clearance K060452 for ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH, Substantially Equivalent on 2007-03-13. Applicant: Neo-Genesis.

Clearance details

Applicant
Neo-Genesis
Product code
Code JLX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Portland, OR, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.