HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO— 510(k) K921745

Name: FDA 510(k) clearance K921745
Creator: U.S. Food and Drug Administration
Published: 1992-07-30

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K921745 for HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO, Substantially Equivalent on 1992-07-30. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1992-04-13
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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