A.QC HCT LEVEL 1 AND 2— 510(k) K893562

Name: FDA 510(k) clearance K893562
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K893562 for A.QC HCT LEVEL 1 AND 2, Substantially Equivalent on 1989-07-14. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 2.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code GLK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1989-05-09
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Download summary PDF View on FDA.gov ↗

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