510(k) K863841— TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE

Substantially Equivalent

Hybritech, Inc.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1986-10-01
Decision date: 1986-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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