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510(k) K833062

SERUM CHOLINESTERASE REAGENT SET by Sterling Biochemical, Inc. — Product Code DLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1983
Date Received
September 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

Other clearances by Sterling Biochemical, Inc.

  • K844998 — GLUCOSE(HEXOKINASE) REAGENT SET (January 18, 1985)
  • K844251 — ALT/GPT REAGENT SET (January 8, 1985)
  • K843332 — ALKALINE PHOSPHATASE REAGENT SET (September 14, 1984)
  • K842521 — AST/GOT REAGENT SET UV RATE (August 12, 1984)
  • K840064 — UREA NITROGEN REAGENT SET (June 14, 1984)
  • K834084 — HYDROXYBUTYRATE DEHYDROGENASE REAGENT (February 4, 1984)
  • K834045 — URIC ACID REAGENT SET (January 30, 1984)
  • K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAY (January 13, 1984)
  • K831874 — LIPASE REAGENT SET (August 12, 1983)
  • K831415 — LACTIC DEHYDROGENASE REAGENT SET (June 16, 1983)

Other clearances for product code DLI

  • K950180 — DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (March 15, 1995)
  • K930208 — CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO (April 20, 1993)
  • K860350 — SERUM CHOLINESTERASE REAGENT SET (April 24, 1986)
  • K860641 — EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 (April 3, 1986)
  • K771024 — CHOLINESTERASE REAGENT SYSTEM (July 15, 1977)