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510(k) K152776

Glocyte Automated Cell Counter System by Advanced Instruments, Inc. — Product Code GKL

K152776 is an FDA 510(k) premarket notification submitted by Advanced Instruments, Inc. for the device "Glocyte Automated Cell Counter System". The FDA issued a decision of Substantially Equivalent on May 27, 2016. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Advanced Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2016
Date Received
September 25, 2015
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 Advanced Instruments, Inc.

  • K120631 — PATIENT MONITOR (May 25, 2012)
  • K112465 — VITAL SIGNS MONITOR (September 14, 2011)
  • K965036 — THE ADVANCED OSMOMETER (3900) (February 20, 1997)
  • K962056 — ADVANCED MICRO-OSMOMETER MODEL 3300 (July 11, 1996)
  • K930526 — INTERMITTENT COMPRESSION SYSTEM MODEL 5000 (November 18, 1993)
  • K925970 — MODEL 3D3 OSMOMETER (July 9, 1993)
  • K911092 — OSMOMETER MODEL 2400 (May 22, 1991)
  • K873642 — OSMOMETER MODEL 110 (October 20, 1987)
  • K863516 — ELECTRONIC METAL LOCATOR MODEL MD-1 (September 30, 1986)
  • K842784 — CEREGROTRAC (January 10, 1985)

Other clearances for product code GKL

  • 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)
  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)

FDA data resources