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510(k) K981872

SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 by Diagnostic Chemicals , Ltd. — Product Code DKJ

K981872 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40". The FDA issued a decision of Substantially Equivalent on June 29, 1998. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Diagnostic Chemicals , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1998
Date Received
May 28, 1998
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 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 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)
  • 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)
  • K946000 — ABUSCREEN ONLINE(R) CALIBRATORS (January 25, 1995)

FDA data resources