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510(k) K955633

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 by Diagnostic Chemicals , Ltd. — Product Code DIC

K955633 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03". The FDA issued a decision of Substantially Equivalent on May 24, 1996. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Diagnostic Chemicals , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1996
Date Received
December 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
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)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)

Other clearances for product code DIC

  • K250609 — Sober Self-Test (September 15, 2025)
  • K181553 — Immunalysis Ethyl Alcohol Enzyme Assay (October 31, 2018)
  • K121247 — ALCO-SCREEN (March 22, 2013)
  • K121256 — ALCO-SCREEN 02 (September 12, 2012)
  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K092273 — RANDOX ETHANOL ASSAY (November 1, 2010)
  • K093879 — MISSION SALIVA ALCOHOL TEST STRIP (August 6, 2010)
  • K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22) (August 24, 2007)
  • K070853 — DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (June 13, 2007)

FDA data resources