TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST— 510(k) K852751

Name: FDA 510(k) clearance K852751
Creator: U.S. Food and Drug Administration
Published: 1985-08-20

Substantially Equivalent

Preco, Inc.

FDA 510(k) clearance K852751 for TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST, Substantially Equivalent on 1985-08-20. Applicant: Preco, Inc.. Device class: 2.

Clearance details

Applicant: Preco, Inc.
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1985-06-28
Decision date: 1985-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

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