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510(k) K930208

CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO by Heraeus Kulzer, Inc. — Product Code DLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
January 15, 1993
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 Heraeus Kulzer, Inc.

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  • K120914 — FLEXITIME FAST & SCAN LIGHT FLOW (July 25, 2012)
  • K113574 — FLEXITIME MONOPHASE PRO SCAN (July 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (December 14, 2011)
  • K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (September 29, 2011)
  • K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (April 29, 2011)
  • K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCA (December 21, 2010)
  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CAR (September 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)

Other clearances for product code DLI

  • K950180 — DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD (March 15, 1995)
  • 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)