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510(k) K902155

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) by Hichem Diagnostics — Product Code JIM

K902155 is an FDA 510(k) premarket notification submitted by Hichem Diagnostics for the device "HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)". The FDA issued a decision of Substantially Equivalent on June 12, 1990. The device falls under product code JIM (Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Hichem Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1990
Date Received
May 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Hichem Diagnostics

  • K981794 — HICHEM CALCIUM REAGENT KIT (July 29, 1998)
  • K963383 — HICHEM ALP/AMP REAGENT KIT (September 23, 1996)
  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009 (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)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)

Other clearances for product code JIM

  • K790772 — CHEMTAB (June 15, 1979)

FDA data resources