BAKER TDM THEOPHYLLINE ASSAY— 510(k) K873596

Name: FDA 510(k) clearance K873596
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Baker Instructions Corp.

FDA 510(k) clearance K873596 for BAKER TDM THEOPHYLLINE ASSAY, Substantially Equivalent on 1987-10-20. Applicant: Baker Instructions Corp.. Device class: 2.

Clearance details

Applicant: Baker Instructions Corp.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1987-09-04
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, VA, US

Download summary PDF View on FDA.gov ↗

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