THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE— 510(k) K012943

Name: FDA 510(k) clearance K012943
Creator: U.S. Food and Drug Administration
Published: 2002-01-18

Substantially Equivalent

Quantech , Ltd.

FDA 510(k) clearance K012943 for THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE, Substantially Equivalent on 2002-01-18. Applicant: Quantech , Ltd.. Device class: 2.

Clearance details

Applicant: Quantech , Ltd.
Product code: Code NAL
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2001-08-31
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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