OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)— 510(k) K871726

Name: FDA 510(k) clearance K871726
Creator: U.S. Food and Drug Administration
Published: 1987-07-27

Substantially Equivalent

Monoclonal Antibodies, Inc.

FDA 510(k) clearance K871726 for OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY), Substantially Equivalent on 1987-07-27. Applicant: Monoclonal Antibodies, Inc.. Device class: 1.

Clearance details

Applicant: Monoclonal Antibodies, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-05-05
Decision date: 1987-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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