HYBRITECH IMMUNOCHEMISTRY ANALYZER— 510(k) K852385

Name: FDA 510(k) clearance K852385
Creator: U.S. Food and Drug Administration
Published: 1985-07-12

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K852385 for HYBRITECH IMMUNOCHEMISTRY ANALYZER, Substantially Equivalent on 1985-07-12. Applicant: Hybritech, Inc.. Device class: 1.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JJF
Device class: Class 1
Regulation: 21 CFR 862.2170
Advisory panel: Clinical Chemistry
Date received: 1985-06-05
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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