STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK, TEST SYSTEM - Bhcg Calpak

• • Terminated Z-0874-06 FDA Unclassified (pre-2012) ·initiated 3 Apr 2006

  Foil sealing of theTestPak 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-0880-06 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.

510(k) Number

K003696 ↗

FDA Product Code

DHA

Models / Variants

Cbhcg

Bhcg Calpak

Model Cbhcg-C

Bhcg Dilpak

Mod

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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