510(k) K080322— HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200

Substantially Equivalent

Hycor Biomedical, Inc.

Clearance details

Applicant: Hycor Biomedical, Inc.
Product code: 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

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