GOAT ANTI-HUMAN KAPPA AFFINITY— 510(k) K832260

Name: FDA 510(k) clearance K832260
Creator: U.S. Food and Drug Administration
Published: 1983-10-31

Substantially Equivalent

Gelco Diagnostics, Inc.

FDA 510(k) clearance K832260 for GOAT ANTI-HUMAN KAPPA AFFINITY, Substantially Equivalent on 1983-10-31. Applicant: Gelco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Gelco Diagnostics, Inc.
Product code: Code DEO
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1983-06-30
Decision date: 1983-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K831904 — RABBIT ANTISERUM TO HUMAN KAPPA LIGHT1983-07-19

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K832256 — GOAT ANTI-HUMAN IMMUNOGLOBULINS-1983-10-31
K832258 — GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC1983-10-31
K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS1983-10-31
K832263 — FITC GOAT ANTI-HUMAN IGA A CHAIN1983-10-31
K832265 — FITC GOAT ANTI-HUMAN IGM H CHAIN1983-10-31

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