NAL · Class II · 21 CFR 862.1155

FDA Product Code NAL: Test, Immunoassay, Biosensor, Hcg

Leading manufacturers include Quantech , Ltd..

2
Total
2
Cleared
234d
Avg days
1999
Since

FDA 510(k) Cleared Test, Immunoassay, Biosensor, Hcg Devices (Product Code NAL)

2 devices
1–2 of 2
Cleared Jan 18, 2002
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
K012943
Quantech , Ltd.
Chemistry · 140d
Cleared Dec 21, 1999
QUANTECH TOTAL B-HCG ASSAY
K990258
Quantech , Ltd.
Chemistry · 328d

About Product Code NAL - Regulatory Context