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510(k) K121823

CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC by Wescor, Inc. — Product Code JFS

K121823 is an FDA 510(k) premarket notification submitted by Wescor, Inc. for the device "CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC". The FDA issued a decision of Substantially Equivalent on March 27, 2013. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. Wescor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2013
Date Received
June 21, 2012
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 Wescor, Inc.

  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K863395 — WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER (May 24, 1988)
  • K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (May 13, 1988)
  • K881512 — WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY (April 18, 1988)
  • K880544 — WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY (April 1, 1988)
  • K853973 — WESCOR MODEL 3700 WEBSTER SWEAT INDUCER (October 16, 1985)
  • K834214 — WESCOR 5500 VAPOR PRESSURE OSMOMETER (March 30, 1984)
  • K834208 — COLLOID OSMOMETER 4400 (March 23, 1984)
  • K840472 — SYS MACRODUCT SWEAT COLLECTION SYS 3600 (March 19, 1984)
  • K830429 — WEIL PERFUSOMETER #100 (October 31, 1983)

Other clearances for product code JFS

  • 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)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)

FDA data resources