510(k) K011551— SURE CHECK PREGNANCY TEST

Substantially Equivalent

Chembio Diagnostic Systems, Inc.

Clearance details

Applicant: Chembio Diagnostic Systems, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2001-05-18
Decision date: 2001-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Beverly, MA, US

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