QM300 PREALBUMIN ANTIBODY PACK— 510(k) K883002

Name: FDA 510(k) clearance K883002
Creator: U.S. Food and Drug Administration
Published: 1988-09-22

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K883002 for QM300 PREALBUMIN ANTIBODY PACK, Substantially Equivalent on 1988-09-22. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1988-07-18
Decision date: 1988-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.