Home / 510(k) Clearances / K873425

510(k) K873425

EASY-TEST SALICYLATE (SAL) #16691 by Em Diagnostic Systems, Inc. — Product Code DKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1987
Date Received
August 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Salicylate
Device Class
Class II
Regulation Number
862.3830
Review Panel
TX
Submission Type

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

Other clearances for product code DKJ

  • K093939 — ADVIA CHEMISTRY SALICYLATE REAGENT (May 19, 2010)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K020794 — SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 11, 2002)
  • K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (February 15, 2002)
  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K981872 — SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (June 29, 1998)
  • K980032 — SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (March 2, 1998)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)
  • K961131 — SALICYLATE ASSAY (April 29, 1996)
  • K951290 — AXSYM SALICYLATE (August 8, 1995)