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510(k) K950180

DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code DLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1995
Date Received
January 17, 1995
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 E.I. Dupont DE Nemours & Co., Inc.

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  • K953724 — CRONEX RADIATION THERAPY CASSETTE (September 6, 1995)
  • K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE (September 6, 1995)
  • K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD (June 1, 1995)
  • K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 13, 1995)
  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950136 — URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

Other clearances for product code DLI

  • 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)
  • K771024 — CHOLINESTERASE REAGENT SYSTEM (July 15, 1977)