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510(k) K800587

NSI WASH SOLUTION CONCENTRATE by Nobel Scientific Industries, Inc. — Product Code JJC

K800587 is an FDA 510(k) premarket notification submitted by Nobel Scientific Industries, Inc. for the device "NSI WASH SOLUTION CONCENTRATE". The FDA issued a decision of Substantially Equivalent on August 8, 1980. 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. Nobel Scientific Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1980
Date Received
March 17, 1980
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 Nobel Scientific Industries, Inc.

  • K854717 — NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 (January 14, 1986)
  • K854716 — NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 (January 7, 1986)
  • K854718 — NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (December 19, 1985)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K844782 — NSI ELT-D DILUTING FLUID 4000ML (March 5, 1985)
  • K823283 — FLUSHING SOLUTION (December 3, 1982)
  • K812866 — ASTRA REAGENT CONCENTRATE SYSTEM (December 17, 1981)
  • K810549 — THERMAL PRINTER PAPER (April 8, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K802518 — BUN REAGENT ASTRA 4 & 8 ANALYZERS (November 12, 1980)

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)
  • K870998 — TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (May 26, 1987)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)

FDA data resources