Last synced on 14 November 2025 at 11:06 pm

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE

Page Type
Cleared 510(K)
510(k) Number
K012943
510(k) Type
Traditional
Applicant
QUANTECH LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/2002
Days to Decision
140 days
Submission Type
Summary

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE

Page Type
Cleared 510(K)
510(k) Number
K012943
510(k) Type
Traditional
Applicant
QUANTECH LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/2002
Days to Decision
140 days
Submission Type
Summary