PREGNA-CERT, SLIDE PREGNANCY TEST— 510(k) K831180

Name: FDA 510(k) clearance K831180
Creator: U.S. Food and Drug Administration
Published: 1983-05-27

Substantially Equivalent

Diagnostic Specialties

FDA 510(k) clearance K831180 for PREGNA-CERT, SLIDE PREGNANCY TEST, Substantially Equivalent on 1983-05-27. Applicant: Diagnostic Specialties. Device class: 2.

Clearance details

Applicant: Diagnostic Specialties
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-04-11
Decision date: 1983-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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