QM300 TRANSFERRIN ANTIBODY PACK— 510(k) K873789

Name: FDA 510(k) clearance K873789
Creator: U.S. Food and Drug Administration
Published: 1987-10-07

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K873789 for QM300 TRANSFERRIN ANTIBODY PACK, Substantially Equivalent on 1987-10-07. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1987-09-17
Decision date: 1987-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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