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510(k) K833971

QUICK-COUNT by Seragen Diagnostics, Inc. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
November 16, 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 Seragen Diagnostics, Inc.

  • K872148 — VIVID CHLAMYDIA(TM) (August 19, 1987)
  • K851663 — QUICK-COUNT HEMATOLOGY CONTROLS (July 23, 1985)
  • K852260 — QUICK-CHEM CALIBRATION SET (July 22, 1985)
  • K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN) (June 25, 1985)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K850209 — QUICK-LYTE (February 27, 1985)
  • K844743 — SERATEST ENA(RNP/SM) DETERMINATION (February 4, 1985)
  • K842563 — SERATEST DNA DETERMINATION (October 25, 1984)
  • K841504 — QUICK-COUNT PLUS 2 (June 11, 1984)
  • K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM (April 13, 1984)

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  • 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)