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510(k) K900685

CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER by Texas Intl. Laboratories, Inc. — Product Code KQG

K900685 is an FDA 510(k) premarket notification submitted by Texas Intl. Laboratories, Inc. for the device "CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400. Texas Intl. Laboratories, Inc. has at least 9 other 510(k) clearances on record.

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
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
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)
  • 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 KQG

  • K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (August 16, 2005)
  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K862047 — COAGULATOR (8 CHANNEL) (September 29, 1986)
  • K852492 — COAGULATOR (August 13, 1985)
  • K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER (June 24, 1985)
  • K823131 — KOAGULAB 40-A AUTOMATED COAGULATION SYS (December 9, 1982)

FDA data resources