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510(k) K860350

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1986
Date Received
January 30, 1986
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 Diagnostics, Inc.

  • K921412 — MICROPROTEIN REAGENT SET (January 21, 1993)
  • K914609 — TRIGLYCERIDES REAGENT SET (November 7, 1991)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K914040 — PHOSPHOLIPID REAGENT SET (October 30, 1991)
  • K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (July 29, 1986)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (July 1, 1986)
  • K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV) (July 1, 1986)
  • K862209 — ALT (SGPT) REAGENT SET (UV RATE) (June 25, 1986)
  • K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (June 16, 1986)

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)
  • 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)