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510(k) K981794

HICHEM CALCIUM REAGENT KIT by Hichem Diagnostics — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1998
Date Received
May 21, 1998
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

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  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

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