Home / 510(k) Clearances / K892329

510(k) K892329

OSMOMETER STANDARD SOLUTIONS by D.R.G. Scientific Industries — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
April 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by D.R.G. Scientific Industries

  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K863880 — BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. (November 24, 1986)
  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)