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510(k) K860166

PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 by Diagnostic Technology, Inc. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
January 17, 1986
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

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  • K890819 — HSV-CHECK(TM) TEST KIT (June 20, 1989)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)
  • K863408 — EBV/VCA-CHECK(TM) ANTIGEN SLIDES (November 28, 1986)
  • K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (May 7, 1986)
  • K853036 — PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 (November 5, 1985)

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