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510(k) K832890

HEMACOMP 7 OR HEMATIL 7 by Texas Intl. Laboratories, Inc. — Product Code GKL

K832890 is an FDA 510(k) premarket notification submitted by Texas Intl. Laboratories, Inc. for the device "HEMACOMP 7 OR HEMATIL 7". The FDA issued a decision of Substantially Equivalent on October 19, 1983. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Texas Intl. Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1983
Date Received
August 26, 1983
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

Other clearances by Texas Intl. Laboratories, Inc.

  • K953643 — HEMATIL 18 (H-18) (March 22, 1996)
  • K904031 — CHEMA CHOL CHOLESTEROL SYSTEM (March 11, 1991)
  • K900684 — RDW AND MPV INDICES ON HEMAT 12 (April 16, 1990)
  • 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)
  • K831649 — THERMOMIXER S213-PHOTOANALYZER S263 (August 24, 1983)

Other clearances for product code GKL

  • K152776 — Glocyte Automated Cell Counter System (May 27, 2016)
  • K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE (August 31, 2010)
  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (December 7, 2005)
  • K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE (March 23, 2005)
  • K032677 — SYSMEX POCH-100I (February 11, 2004)
  • K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (September 11, 2002)
  • K001683 — SYSMEX R-500 (August 21, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)

FDA data resources