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510(k) K850239

SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- by Toa Medical Electronics USA, Inc. — Product Code GIF

K850239 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-". The FDA issued a decision of Substantially Equivalent on April 1, 1985. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diluent, Blood Cell
Device Class
Class I
Regulation Number
864.8200
Review Panel
HE
Submission Type

Other clearances by Toa Medical Electronics USA, Inc.

  • K936023 — SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER (May 2, 1994)
  • K933886 — TOA MEDICAL ELECTRONICS CA-5000 (January 27, 1994)
  • K931149 — CA-1000 AUTOMATED COAGULATION ANALYZER (November 3, 1993)
  • K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES (April 29, 1992)
  • K914744 — SYSMEX NE-1500, MODIFICATION (December 30, 1991)
  • K912494 — SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER (September 10, 1991)
  • K910849 — SYSMEX F-810 (July 26, 1991)
  • K911172 — SYSMEX F-610 (July 26, 1991)
  • K911173 — SYSMEX F-310 (July 26, 1991)
  • K910745 — HEMOGLOBIN REAGENT (July 11, 1991)

Other clearances for product code GIF

  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (July 25, 1988)
  • K882267 — SYSMEX QUICKLYSER-II (QLS-200A) (July 12, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K850095 — LASER-DIL (March 29, 1985)

FDA data resources