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510(k) K771024

CHOLINESTERASE REAGENT SYSTEM by American Monitor Corp. — Product Code DLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1977
Date Received
June 8, 1977
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 American Monitor Corp.

  • K896000 — ASPARTATE AMINOTRANFERASE (AST) (January 11, 1990)
  • K895999 — PHOSPHORUS (January 11, 1990)
  • K896001 — ALANINE AMINOTRANSFERASE (ALT) (November 13, 1989)
  • K895423 — ACCESS CHEMISTRY ANALYZER (October 4, 1989)
  • K893137 — EXCEL (TM) CHEMISTRY ANALYZER (August 10, 1989)
  • K892331 — ENZYMATIC UREA NITROGEN REAGENT SET (June 20, 1989)
  • K893479 — CHOLESTEROL REAGENT SET (June 19, 1989)
  • K892002 — NEOCHROME(R) III GLUCOSE (June 12, 1989)
  • K890312 — GAMMA-GLUTAMYLTRANSFERASE (March 24, 1989)
  • K890034 — PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) (February 3, 1989)

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)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)