Home / 510(k) Clearances / K884601

510(k) K884601

TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE by Technicon Instruments Corp. — Product Code CHJ

K884601 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), a Class II device regulated under 21 CFR 862.1170. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
November 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mercuric Thiocyanate, Colorimetry, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Technicon Instruments Corp.

  • K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (November 27, 1991)
  • K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (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)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (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 CHJ

  • K010670 — PICCOLO CHLORIDE TEST SYSTEM (April 26, 2001)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K943006 — CHLORIDE QVET (December 7, 1994)
  • K934136 — OLYMPUS CHLORIDE REAGENT, MODIFICATION (November 5, 1993)
  • K932528 — OLYMPUS CHLORID REAGENT, MODIFIED (September 17, 1993)
  • K925338 — OLYMPUS CHLORIDE REAGENT (December 11, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923610 — OLYMPUS CHLORIDE REAGENT (October 2, 1992)
  • K923036 — URINE CHLORIDE (September 9, 1992)
  • K911297 — CHLORIDE REAGENT (April 16, 1991)

FDA data resources