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510(k) K012943

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE by Quantech , Ltd. — Product Code NAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2002
Date Received
August 31, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Immunoassay, Biosensor, Hcg
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Quantech , Ltd.

  • K990258 — QUANTECH TOTAL B-HCG ASSAY (December 21, 1999)
  • K984433 — QUANTECH CK-MB ASSAY (November 1, 1999)

Other clearances for product code NAL

  • K990258 — QUANTECH TOTAL B-HCG ASSAY (December 21, 1999)