GILFORD IMMUNOGLOBULIN M REAGENT— 510(k) K853469

Substantially Equivalent

Gilford

FDA 510(k) clearance K853469 for GILFORD IMMUNOGLOBULIN M REAGENT, Substantially Equivalent on 1985-09-16. Applicant: Gilford. Device class: 2.

Clearance details

Applicant: Gilford
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1985-08-19
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oberlin, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gilford

K853465 — GILFORD IMMUNOGLOBULIN G REAGENT1985-09-16
K853466 — GILFORD C3 COMPLEMENT REAGENT1985-09-16
K853467 — GILFORD IMMUNOGLOBULIN A REAGENT1985-09-16
K853468 — GILFORD C4 COMPLEMENT REAGENT1985-09-16
K851202 — GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL1985-04-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.