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510(k) K882038

GDS ENZYMATIC SALICYLATE REAGENT by Gds Technology, LLC — Product Code DKJ

K882038 is an FDA 510(k) premarket notification submitted by Gds Technology, LLC for the device "GDS ENZYMATIC SALICYLATE REAGENT". The FDA issued a decision of Substantially Equivalent on June 24, 1988. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Gds Technology, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1988
Date Received
May 16, 1988
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 Gds Technology, LLC

  • K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARD (February 11, 2002)
  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K992132 — CHOLESITE TEST SYSTEM (August 20, 1999)
  • K973649 — HEMOSITE TEST SYSTEM (August 31, 1998)
  • K971145 — GLUCOSITE TEST SYSTEM (September 17, 1997)
  • K911801 — KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON (July 1, 1991)
  • K880829 — GDS ENZYMATIC ACETAMINOPHEN REAGENT (May 27, 1988)

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)

FDA data resources