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510(k) K951818

HICHEM ALT REAGENT KIT by Hi Chem, Inc. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
April 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Hi Chem, Inc.

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  • 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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