QUICK-CHEM CALIBRATION SET— 510(k) K852260

Name: FDA 510(k) clearance K852260
Creator: U.S. Food and Drug Administration
Published: 1985-07-22

Substantially Equivalent

Seragen Diagnostics, Inc.

FDA 510(k) clearance K852260 for QUICK-CHEM CALIBRATION SET, Substantially Equivalent on 1985-07-22. Applicant: Seragen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Seragen Diagnostics, Inc.
Product code: Code JIW
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1985-05-24
Decision date: 1985-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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