H-I-M-TEST FOR DETECTING HUMAN CHOR. GON— 510(k) K800055

Name: FDA 510(k) clearance K800055
Creator: U.S. Food and Drug Administration
Published: 1980-01-29

Substantially Equivalent

Technam, Inc.

FDA 510(k) clearance K800055 for H-I-M-TEST FOR DETECTING HUMAN CHOR. GON, Substantially Equivalent on 1980-01-29. Applicant: Technam, Inc.. Device class: 2.

Clearance details

Applicant: Technam, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1980-01-10
Decision date: 1980-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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