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510(k) K955498

CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 by Diagnostic Chemicals , Ltd. — Product Code DIH

K955498 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05". The FDA issued a decision of Substantially Equivalent on January 24, 1996. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Diagnostic Chemicals , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
December 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

Other clearances by Diagnostic Chemicals , Ltd.

  • K070383 — ENZYMATIC CREATININE ASSAY (265 SERIES) (June 22, 2007)
  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (January 19, 2007)
  • K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (April 28, 2006)
  • K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (April 24, 2006)
  • K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (November 10, 2005)
  • K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20 (July 5, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- (December 27, 2004)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K041928 — HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (November 23, 2004)

Other clearances for product code DIH

  • K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (February 7, 2011)
  • K061093 — CHOLINESTERASE GEN.2 TEST SYSTEM (July 3, 2006)
  • K051444 — SENTINEL CHOLINESTERASE LIQUID (June 20, 2005)
  • K030045 — OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (February 21, 2003)
  • K023992 — WIENER LAB COLINESTERASA AA (February 12, 2003)
  • K013750 — ADVIA 1650 CHOLINESTERASE ASSAY (January 18, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001344 — ADVIA IMS (June 26, 2000)
  • K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (November 26, 1996)
  • K943367 — IL TEST CHOLINESTERASE (February 5, 1996)

FDA data resources