Stratus (R) Cs Myoglobin (Myo) Testpak

• • Terminated Z-0884-06 FDA Unclassified (pre-2012) ·initiated 3 Apr 2006

  Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

• • Terminated Z-0878-06 FDA Unclassified (pre-2012) ·initiated 3 Apr 2006

  Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

510(k) Number

K984065 ↗

FDA Product Code

DDR

Device Class

Class II

Regulation

21 CFR Part 866.5680

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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