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510(k) K900717

TECHNICON TESTPOINT(TM) LIGAND CONTROL by Technicon Instruments Corp. — Product Code JJY

K900717 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON TESTPOINT(TM) LIGAND CONTROL". The FDA issued a decision of Substantially Equivalent on April 26, 1990. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1990
Date Received
February 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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)
  • K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (September 27, 1990)
  • K903824 — DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY (September 27, 1990)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (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 JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources