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510(k) K893895

HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL by Intercare Diagnostics, Inc. — Product Code JPK

K893895 is an FDA 510(k) premarket notification submitted by Intercare Diagnostics, Inc. for the device "HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL". The FDA issued a decision of Substantially Equivalent on July 25, 1989. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Intercare Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1989
Date Received
May 30, 1989
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 Intercare Diagnostics, Inc.

  • K941938 — THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE (August 5, 1994)
  • K920569 — INDXTM DIP-S-TICKSTM (February 9, 1993)
  • K901597 — INDX DIP S TICKS (December 21, 1990)
  • K862948 — CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) (October 17, 1986)

Other clearances for product code JPK

  • K160590 — XN CHECK (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K141964 — XN CHECK (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