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510(k) K853722

PLT-4 PLATELET ANALYZER by Texas Intl. Laboratories, Inc. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1986
Date Received
September 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

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  • K832890 — HEMACOMP 7 OR HEMATIL 7 (October 19, 1983)
  • K831649 — THERMOMIXER S213-PHOTOANALYZER S263 (August 24, 1983)

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