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510(k) K990258

QUANTECH TOTAL B-HCG ASSAY by Quantech , Ltd. — Product Code NAL

K990258 is an FDA 510(k) premarket notification submitted by Quantech , Ltd. for the device "QUANTECH TOTAL B-HCG ASSAY". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code NAL (Test, Immunoassay, Biosensor, Hcg), a Class II device regulated under 21 CFR 862.1155. Quantech , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
January 27, 1999
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.

  • K012943 — THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST (January 18, 2002)
  • K984433 — QUANTECH CK-MB ASSAY (November 1, 1999)

Other clearances for product code NAL

  • K012943 — THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST (January 18, 2002)

FDA data resources