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510(k) K902673

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND by Hi Chem, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1990
Date Received
June 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Hi Chem, Inc.

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  • K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (May 13, 1994)
  • 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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