ACA IMMUNOGLOBIN M TEST PACK— 510(k) K812632

Name: FDA 510(k) clearance K812632
Creator: U.S. Food and Drug Administration
Published: 1981-09-29

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K812632 for ACA IMMUNOGLOBIN M TEST PACK, Substantially Equivalent on 1981-09-29. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1981-09-15
Decision date: 1981-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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