K012567

Substantially Equivalent

MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

Applicant: Corgenix, Inc.
Product code: MID
Advisory panel: Immunology
Date received: 2001-08-09
Decision date: 2001-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Westminster, CO, US

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