OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP— 510(k) K930185

Name: FDA 510(k) clearance K930185
Creator: U.S. Food and Drug Administration
Published: 1993-03-04

Substantially Equivalent

Princeton Biomedix

FDA 510(k) clearance K930185 for OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP, Substantially Equivalent on 1993-03-04. Applicant: Princeton Biomedix. Device class: 1.

Clearance details

Applicant: Princeton Biomedix
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1993-01-14
Decision date: 1993-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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