GUINEA PIG COMPLEMENT VIRUS ANTIBODY— 510(k) K812369

Name: FDA 510(k) clearance K812369
Creator: U.S. Food and Drug Administration
Published: 1981-09-08

Substantially Equivalent

Dutchland Laboratories, Inc.

FDA 510(k) clearance K812369 for GUINEA PIG COMPLEMENT VIRUS ANTIBODY, Substantially Equivalent on 1981-09-08. Applicant: Dutchland Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dutchland Laboratories, Inc.
Product code: Code KTQ
Device class: Class 1
Regulation: 21 CFR 866.4100
Advisory panel: Immunology
Date received: 1981-08-20
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K791117 — RABBIT COMPLEMENT1979-08-03
K790380 — LOW-TOX-H RABBIT COMPLEMENT1979-03-21

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