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510(k) K841809

COUNT-A-PART PLUS by Diagnostic Technology, Inc. — Product Code JPK

K841809 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "COUNT-A-PART PLUS". The FDA issued a decision of Substantially Equivalent on November 30, 1984. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1984
Date Received
May 1, 1984
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 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)
  • K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (May 7, 1986)
  • K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (April 4, 1986)

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