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510(k) K843378

ETHYL ALCOHOL ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa) — Product Code DMT

K843378 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals, Ltd. (Usa) for the device "ETHYL ALCOHOL ASSAY KIT". The FDA issued a decision of Substantially Equivalent on September 14, 1984. The device falls under product code DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet), a Class II device regulated under 21 CFR 862.3040. Diagnostic Chemicals, Ltd. (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1984
Date Received
August 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

Other clearances by Diagnostic Chemicals, Ltd. (Usa)

  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K974874 — BILIRUBIN-SL (TOTAL) ASSAY (February 12, 1998)
  • K932556 — AMMONIA ASSAY CAT. NO. 200-02 (August 2, 1994)
  • K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (December 10, 1993)
  • K932555 — DC-LINEATE CAT. NO. SE-091 (August 19, 1993)
  • K925877 — DC-UIBC-CAL (March 18, 1993)
  • K912825 — MAGNESIUM ASSAY KIT, CAT.# 100-12 (July 26, 1991)
  • K895964 — DCL SYPHILIS-M CATALOG NO. 600-80 (January 8, 1991)
  • K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (December 26, 1990)
  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)

Other clearances for product code DMT

  • K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (April 10, 2000)
  • K971506 — SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (June 3, 1997)
  • K934273 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (March 21, 1994)
  • K923783 — ETHYL ALCOHOL ASSAY (January 21, 1993)
  • K864894 — EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (January 9, 1987)
  • K810467 — EMIT-ST SERUM ETHYL ALCOHOL ASSAY (March 6, 1981)
  • K802621 — EMIT-STM ETHYL ALCOHOL ASSAY (October 31, 1980)

FDA data resources