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510(k) K941764

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 by Hi Chem, Inc. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1994
Date Received
March 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Hi Chem, Inc.

  • K960084 — HICHEM GLUCOSE/HK REAGENT KIT (April 4, 1996)
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  • K943684 — HICHEM ENZYME VERIFIER KIT (October 4, 1994)
  • K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (July 17, 1990)
  • K863617 — ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) (October 24, 1986)
  • 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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