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510(k) K984433

QUANTECH CK-MB ASSAY by Quantech , Ltd. — Product Code MYT

K984433 is an FDA 510(k) premarket notification submitted by Quantech , Ltd. for the device "QUANTECH CK-MB ASSAY". The FDA issued a decision of Substantially Equivalent on November 1, 1999. The device falls under product code MYT (Biosensor, Immunoassay, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Quantech , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1999
Date Received
December 14, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biosensor, Immunoassay, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
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)
  • K990258 — QUANTECH TOTAL B-HCG ASSAY (December 21, 1999)

Other clearances for product code MYT

  • K051433 — I-STAT CREATINE KINASE MB (CK-MB) (December 15, 2005)
  • K033155 — BIOCENTREX CARDIAC PANEL (January 12, 2004)

FDA data resources