CONTROL SERUMS FOR NONTREPONEMAL TEST— 510(k) K810119

Name: FDA 510(k) clearance K810119
Creator: U.S. Food and Drug Administration
Published: 1981-02-09

Substantially Equivalent

Hillside Acres, Inc.

FDA 510(k) clearance K810119 for CONTROL SERUMS FOR NONTREPONEMAL TEST, Substantially Equivalent on 1981-02-09. Applicant: Hillside Acres, Inc.. Device class: 2.

Clearance details

Applicant: Hillside Acres, Inc.
Product code: Code GMP
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1981-01-16
Decision date: 1981-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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