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510(k) K834371

TRI-COUNT 10 by Hematology Marketing Assoc. — Product Code JPK

K834371 is an FDA 510(k) premarket notification submitted by Hematology Marketing Assoc. for the device "TRI-COUNT 10". The FDA issued a decision of Substantially Equivalent on March 9, 1984. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Hematology Marketing Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1984
Date Received
December 13, 1983
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 Hematology Marketing Assoc.

  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851375 — TRI-COUNT (July 12, 1985)
  • K850094 — LASER-GLOBIN POWDER (March 29, 1985)
  • K850095 — LASER-DIL (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850096 — LASER-GLOBIN (March 29, 1985)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K843485 — TRI-COUNT LASER (December 12, 1984)
  • K833130 — TRI-COUNT 7 (October 20, 1983)
  • K831306 — HEMACAL (June 16, 1983)

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