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510(k) K883177

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER by Texas Intl. Laboratories, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1988
Date Received
July 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Texas Intl. Laboratories, Inc.

  • K953643 — HEMATIL 18 (H-18) (March 22, 1996)
  • K904031 — CHEMA CHOL CHOLESTEROL SYSTEM (March 11, 1991)
  • K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (April 16, 1990)
  • K900684 — RDW AND MPV INDICES ON HEMAT 12 (April 16, 1990)
  • K884006 — HEMAT 12 (December 5, 1988)
  • K853722 — PLT-4 PLATELET ANALYZER (January 17, 1986)
  • K832886 — FLAME PHOTOMETER T281-T282-T283 (December 8, 1983)
  • K832890 — HEMACOMP 7 OR HEMATIL 7 (October 19, 1983)
  • K831649 — THERMOMIXER S213-PHOTOANALYZER S263 (August 24, 1983)

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