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510(k) K863617

ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) by Hi Chem, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Hi Chem, Inc.

  • K960084 — HICHEM GLUCOSE/HK REAGENT KIT (April 4, 1996)
  • K951818 — HICHEM ALT REAGENT KIT (May 15, 1995)
  • K943684 — HICHEM ENZYME VERIFIER KIT (October 4, 1994)
  • K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (May 13, 1994)
  • K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (July 17, 1990)
  • K862027 — LDP REAGENT CARTRIDGE (NO. 88216) (June 13, 1986)
  • K861893 — GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) (June 5, 1986)
  • K861879 — CK REAGENT CARTRIDGE (PRODUCT NO. 88213) (May 29, 1986)
  • K861283 — AST REAGENT CARTRIDGE (April 28, 1986)
  • K861231 — ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) (April 28, 1986)

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