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510(k) K910881

CONTROL AND LINEARITY by Gds Diagnostics — Product Code DKB

K910881 is an FDA 510(k) premarket notification submitted by Gds Diagnostics for the device "CONTROL AND LINEARITY". The FDA issued a decision of Substantially Equivalent on September 13, 1991. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Gds Diagnostics has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1991
Date Received
March 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Gds Diagnostics

  • K931257 — ACETASITE (July 8, 1993)
  • K910108 — GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (March 4, 1991)
  • K891761 — GDS ENZYMATIC THEOPHYLLINE REAGENT (May 16, 1989)

Other clearances for product code DKB

  • K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (November 25, 2014)
  • K133710 — LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (February 21, 2014)
  • K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT (December 13, 2012)
  • K092266 — RANDOX METHAMPHETAMINE ASSAY (May 9, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLIN (June 18, 2009)
  • K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (June 1, 2009)
  • K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (September 14, 2006)
  • K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (August 25, 2006)
  • K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRAT (May 30, 2006)

FDA data resources