ACA PLASMINOGEN TEST PACK— 510(k) K812625

Name: FDA 510(k) clearance K812625
Creator: U.S. Food and Drug Administration
Published: 1981-09-29

Substantially Equivalent

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

FDA 510(k) clearance K812625 for ACA PLASMINOGEN TEST PACK, Substantially Equivalent on 1981-09-29. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DDX
Device class: Class 1
Regulation: 21 CFR 866.5715
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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K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY1985-05-08

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