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510(k) K860586

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS by Diagnostic Technology, Inc. — Product Code GKL

K860586 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS". The FDA issued a decision of Substantially Equivalent on May 7, 1986. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1986
Date Received
February 19, 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

Other clearances by Diagnostic Technology, Inc.

  • K896378 — LYME-CHECK(TM) TEST KIT (November 5, 1991)
  • K903612 — EBV/EA-CHECK TM TEST KIT (October 16, 1990)
  • K890819 — HSV-CHECK(TM) TEST KIT (June 20, 1989)
  • K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT (June 20, 1989)
  • K891542 — EBNA-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)
  • K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (April 4, 1986)
  • K853036 — PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 (November 5, 1985)

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