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510(k) K770143

TQC CALIBRATION REFERENCE FOR PLATELETS by Technicon Instruments Corp. — Product Code KRY

K770143 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TQC CALIBRATION REFERENCE FOR PLATELETS". The FDA issued a decision of Substantially Equivalent on January 30, 1978. The device falls under product code KRY (Calibrator For Platelet Counting), a Class II device regulated under 21 CFR 864.8175. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1978
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Platelet Counting
Device Class
Class II
Regulation Number
864.8175
Review Panel
HE
Submission Type

Other clearances by Technicon Instruments Corp.

  • K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (November 27, 1991)
  • K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (November 27, 1991)
  • K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (November 22, 1991)
  • K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (September 25, 1991)
  • K912413 — CHEM-LINK DATA BASE MANAGER (July 1, 1991)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (September 27, 1990)
  • K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (September 27, 1990)
  • K903824 — DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY (September 27, 1990)
  • K903306 — TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (August 29, 1990)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)

Other clearances for product code KRY

  • K862122 — S-CAL HEMATOLOGY CALIBRATOR (May 20, 1987)
  • K852016 — LASER PLATELETCAL/MULTIPLE (July 9, 1985)
  • K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR (January 7, 1985)
  • K840794 — S-CAL HEMATOLOGY CALIBRATOR (April 4, 1984)
  • K821851 — CONTROL DIAGNOSTICS PLATELET CONTROL (September 2, 1982)
  • K781601 — TEKNI-CAL (October 10, 1978)
  • K781133 — PC-CALIBRATOR (August 14, 1978)

FDA data resources