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510(k) K953863

HICHEM ISE STANDARDS KIT 70011 by Hichem Diagnostics — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1995
Date Received
August 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K951751 — HICHEM AST REAGENT KIT (August 2, 1995)
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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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