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K101335.pdf

K101335.pdf
Preview of K101335
🔗 Source: accessdata.fda.gov
📊 Size: 164 KB
📄 Pages: 6 pages
⬇️ Downloads: 62

Summary

Streck submitted a 510(k) premarket notification for Cell-CheXTM, a hematology control for body fluids, to the FDA. The device is a stabilized suspension of human red and white blood cells, with monosodium urate crystals in Level 1, used for monitoring total cell counts and white blood cell differentiation in body fluid samples. The FDA determined that Cell-CheXTM is substantially equivalent to the predicate device, Cell-CheXTM (K000076), and may be marketed subject to general controls provisions of the Federal Food, Drug, and Cosmetic Act.

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Description

Streck submitted a 510(k) premarket notification for Cell-CheXTM, a hematology control for body fluids, to the FDA.

Technical Information

  • File Format: PDF
  • File Size: 164 KB
  • Pages: 6
  • Language: EN
  • Total Downloads: 62
  • Last Updated: 6 hours ago

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