510(k) K172512— ACRO HCG Pregnancy Rapid Test

Substantially Equivalent

Acro Biotech, Inc.

Clearance details

Applicant: Acro Biotech, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2017-08-21
Decision date: 2018-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Rancho Cucamonga, CA, US

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