K/K (ASMA/ANA) UNIVERSAL BIOPAK— 510(k) K802299

Name: FDA 510(k) clearance K802299
Creator: U.S. Food and Drug Administration
Published: 1981-01-29

Substantially Equivalent

Bioware Products

FDA 510(k) clearance K802299 for K/K (ASMA/ANA) UNIVERSAL BIOPAK, Substantially Equivalent on 1981-01-29. Applicant: Bioware Products. Device class: 2.

Clearance details

Applicant: Bioware Products
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1980-09-19
Decision date: 1981-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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