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510(k) K870998

TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS by Technicon Instruments Corp. — Product Code JJC

K870998 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS". The FDA issued a decision of Substantially Equivalent on May 26, 1987. The device falls under product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use), a Class I device regulated under 21 CFR 862.2150. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1987
Date Received
March 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
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)
  • 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 JJC

  • K945915 — AVL OMNI ANALYZER (April 5, 1995)
  • K945584 — NOVA 16 ANALYZER (February 8, 1995)
  • K943376 — OPERA SYSTEM (September 14, 1994)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K901141 — PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (April 9, 1990)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K881056 — AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (November 15, 1988)
  • K875105 — TECHNICON SMAC 3 SYSTEM (February 16, 1988)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)
  • K854345 — TECHNICON RA-500 SYSTEM (November 26, 1985)

FDA data resources