QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.— 510(k) K821862

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K821862 for QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM., Substantially Equivalent on 1982-07-06. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant
Kallestad Laboratories, Inc.
Product code
Code LCA
Device class
Class 2
Regulation
21 CFR 862.3880
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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