AMES TDA AMIKACIN— 510(k) K801130

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K801130 for AMES TDA AMIKACIN, Substantially Equivalent on 1980-05-28. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1980-05-12
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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More clearances from Miles Laboratories, Inc.

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K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT1987-12-22
K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER1987-10-28

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