PLATELIA TOXO IGG KIT— 510(k) K894947

Name: FDA 510(k) clearance K894947
Creator: U.S. Food and Drug Administration
Published: 1990-03-23

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K894947 for PLATELIA TOXO IGG KIT, Substantially Equivalent on 1990-03-23. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code LGO
Device class: Class 1
Regulation: 21 CFR 864.7675
Advisory panel: Hematology
Date received: 1989-08-03
Decision date: 1990-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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