CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036— 510(k) K853144

Name: FDA 510(k) clearance K853144
Creator: U.S. Food and Drug Administration
Published: 1985-10-16

Substantially Equivalent

Preco, Inc.

FDA 510(k) clearance K853144 for CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036, Substantially Equivalent on 1985-10-16. Applicant: Preco, Inc.. Device class: 2.

Clearance details

Applicant: Preco, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1985-07-29
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

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