POLYCHACO FIA-ABS TEST FOR SYPHILIS— 510(k) K831296

Name: FDA 510(k) clearance K831296
Creator: U.S. Food and Drug Administration
Published: 1983-07-26

Substantially Equivalent

Parasitic Disease Consultants

FDA 510(k) clearance K831296 for POLYCHACO FIA-ABS TEST FOR SYPHILIS, Substantially Equivalent on 1983-07-26. Applicant: Parasitic Disease Consultants. Device class: 2.

Clearance details

Applicant: Parasitic Disease Consultants
Product code: Code JWL
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1983-04-20
Decision date: 1983-07-26
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.