ASSAY REAGENTS, LSA 290— 510(k) K790588

Name: FDA 510(k) clearance K790588
Creator: U.S. Food and Drug Administration
Published: 1979-05-15

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K790588 for ASSAY REAGENTS, LSA 290, Substantially Equivalent on 1979-05-15. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code JEW
Device class: Class 1
Regulation: 21 CFR 872.6650
Advisory panel: Dental
Date received: 1979-03-27
Decision date: 1979-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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