SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH— 510(k) K842440

Name: FDA 510(k) clearance K842440
Creator: U.S. Food and Drug Administration
Published: 1984-07-27

Substantially Equivalent

Anco Medical Reagents & Assoc.

FDA 510(k) clearance K842440 for SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH, Substantially Equivalent on 1984-07-27. Applicant: Anco Medical Reagents & Assoc.. Device class: 2.

Clearance details

Applicant: Anco Medical Reagents & Assoc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1984-06-21
Decision date: 1984-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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