POLYCHACO INDIRECT IMMUNOFLUORESCENCE— 510(k) K830869

Name: FDA 510(k) clearance K830869
Creator: U.S. Food and Drug Administration
Published: 1983-08-11

Substantially Equivalent

Parasitic Disease Consultants

FDA 510(k) clearance K830869 for POLYCHACO INDIRECT IMMUNOFLUORESCENCE, Substantially Equivalent on 1983-08-11. Applicant: Parasitic Disease Consultants. Device class: 2.

Clearance details

Applicant: Parasitic Disease Consultants
Product code: Code GLZ
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1983-03-18
Decision date: 1983-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION1983-08-12
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Data sourced from openFDA. This site is unofficial and independent of the FDA.