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510(k) K952839

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY by Boehringer Mannheim Corp. — Product Code DML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
June 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K983510 — CHEMSTRIP 101 URINE ANALYZER (October 27, 1998)

Other clearances for product code DML

  • K013538 — ETHANOL (December 14, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K963197 — ON.SITE ALCOHOL (September 19, 1996)
  • K953765 — AXSYM REA ETHANOL (September 27, 1995)
  • K923337 — ON*SITE ALCOHOL (January 12, 1993)
  • K914777 — SIGMA PROCEDURE NO. 333-UV (December 27, 1991)
  • K874382 — RAICHEM(TM) ALCOHOL REAGENT (January 11, 1988)
  • K872180 — KINETIC 610 ETHANOL (July 7, 1987)
  • K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (September 29, 1986)
  • K840769 — PARAMAX ALCOHOL REAGENT (April 13, 1984)