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510(k) K941433

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH by Hichem Diagnostics — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
March 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Hichem Diagnostics

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  • K963383 — HICHEM ALP/AMP REAGENT KIT (September 23, 1996)
  • K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009 (September 6, 1995)
  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K951751 — HICHEM AST REAGENT KIT (August 2, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

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