LYSING AGENT AF— 510(k) K761183

Name: FDA 510(k) clearance K761183
Creator: U.S. Food and Drug Administration
Published: 1977-01-17

Substantially Equivalent

Central Labs. Assoc. MD Pathologists

FDA 510(k) clearance K761183 for LYSING AGENT AF, Substantially Equivalent on 1977-01-17. Applicant: Central Labs. Assoc. MD Pathologists. Device class: 1.

Clearance details

Applicant: Central Labs. Assoc. MD Pathologists
Product code: Code JCE
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1976-12-02
Decision date: 1977-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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