RUBAZYME - M— 510(k) K810835

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K810835 for RUBAZYME - M, Substantially Equivalent on 1981-05-05. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1981-03-25
Decision date: 1981-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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K790122 — RUBANON1979-02-15
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Data sourced from openFDA. This site is unofficial and independent of the FDA.