Home / 510(k) Clearances / K900684

510(k) K900684

RDW AND MPV INDICES ON HEMAT 12 by Texas Intl. Laboratories, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
February 12, 1990
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)
  • K884006 — HEMAT 12 (December 5, 1988)
  • K883177 — H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER (November 30, 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)

Other clearances for product code GKZ

  • K243348 — Athelas Home (February 6, 2026)
  • K251249 — Tru Hematology Test (January 16, 2026)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K240402 — Cito CBC System (February 3, 2025)
  • K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer I (July 5, 2024)
  • K232946 — Yumizen H2500 (May 21, 2024)
  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)