SLIDE TEST FOR PREGNANCY, GRAVINDEX 90— 510(k) K782166

Name: FDA 510(k) clearance K782166
Creator: U.S. Food and Drug Administration
Published: 1979-04-04

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K782166 for SLIDE TEST FOR PREGNANCY, GRAVINDEX 90, Substantially Equivalent on 1979-04-04. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1978-12-29
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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