K080322

Substantially Equivalent

HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200

Applicant: Hycor Biomedical, Inc.
Product code: DHB
Advisory panel: Immunology
Date received: 2008-02-06
Decision date: 2008-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.