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FDA 510(k), K012943, THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
FDA 510(k), K012943, THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
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510(K) Number: K012943
Device Name: THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
Manufacturer: ROBIN J HELLEN
Device Classification Name: Test, Immunoassay, Biosensor, Hcg
Regulation Number: NAL
Classification Product Code: KXA
Date Received: 08/31/2001
Decision Date: 01/18/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
Manufacturer: ROBIN J HELLEN
Device Classification Name: Test, Immunoassay, Biosensor, Hcg
Regulation Number: NAL
Classification Product Code: KXA
Date Received: 08/31/2001
Decision Date: 01/18/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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