Home / 510(k) Clearances / K800585

510(k) K800585

NSI CHLORIDE REAGENT KIT by Nobel Scientific Industries, Inc. — Product Code JFS

K800585 is an FDA 510(k) premarket notification submitted by Nobel Scientific Industries, Inc. for the device "NSI CHLORIDE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. Nobel Scientific Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
March 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coulometric, Chloride
Device Class
Class II
Regulation Number
862.1170
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 JFS

  • K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLOR (March 27, 2013)
  • K923598 — REDI-CHECK PHOTMETER Q.A. (October 14, 1992)
  • K873127 — CHLORIDE REAGENT KIT (October 23, 1987)
  • K830217 — REAGENTS CORNING CHLORIDE METER FOR (February 18, 1983)
  • K823106 — RERMCO TEST CHLORIDE REAGENT (November 16, 1982)
  • K820411 — LIQUIZYME CHLORIDE REAGENT (March 8, 1982)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K810615 — CORNING 925 CHLORIDE METER (March 17, 1981)

FDA data resources