BIOSAMPLER— 510(k) K844615

Substantially Equivalent

Biotek-Caribbean

FDA 510(k) clearance K844615 for BIOSAMPLER, Substantially Equivalent on 1985-03-21. Applicant: Biotek-Caribbean. Device class: 1.

Clearance details

Applicant: Biotek-Caribbean
Product code: Code CBT
Device class: Class 1
Regulation: 21 CFR 868.1100
Advisory panel: Anesthesiology
Date received: 1984-11-27
Decision date: 1985-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santo Domingo, Dom. Rep., DO

Download summary PDF View on FDA.gov ↗

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