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510(k) K852372

CELL-DYN BRAND HEMATOLOGY REAGENTS by Abbott Diagnostics — Product Code JPK

K852372 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN BRAND HEMATOLOGY REAGENTS". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
June 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Abbott Diagnostics

  • K964185 — IMX CA 125 (November 4, 1997)
  • K972182 — ABBOTT STREP A CONTROLS (August 13, 1997)
  • K961439 — ABBOTT CELL-DYN 4000 SYSTEM (October 18, 1996)
  • K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (April 18, 1989)
  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K873408 — MODEL 690 SPECTROPHOTOMETER (September 8, 1987)
  • K872761 — CELL-DYN 610 HEMATOLOGY ANALYZER (August 6, 1987)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources