MICROCHECK LH OVULATION TEST— 510(k) K871602

Name: FDA 510(k) clearance K871602
Creator: U.S. Food and Drug Administration
Published: 1987-06-11

Substantially Equivalent

Syntron Bioresearch, Inc.

FDA 510(k) clearance K871602 for MICROCHECK LH OVULATION TEST, Substantially Equivalent on 1987-06-11. Applicant: Syntron Bioresearch, Inc.. Device class: 1.

Clearance details

Applicant: Syntron Bioresearch, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-04-24
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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