TBD* ONE-STEP OVULATION PREDICTOR TEST— 510(k) K973310

Name: FDA 510(k) clearance K973310
Creator: U.S. Food and Drug Administration
Published: 1997-10-27

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K973310 for TBD* ONE-STEP OVULATION PREDICTOR TEST, Substantially Equivalent on 1997-10-27. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1997-09-03
Decision date: 1997-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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