GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC— 510(k) K802257

Name: FDA 510(k) clearance K802257
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

Protos Laboratories

FDA 510(k) clearance K802257 for GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC, Substantially Equivalent on 1980-10-31. Applicant: Protos Laboratories. Device class: 2.

Clearance details

Applicant: Protos Laboratories
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1980-09-16
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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