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510(k) K853887

LIQUI-SERA CHEM. MULTIPLE CALIBRATORS by Biodiagnostic Intl — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1985
Date Received
September 19, 1985
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 Biodiagnostic Intl

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  • K881430 — LIQUI-SERA SERUM ALCOHOL CONTROLS (July 8, 1988)
  • K874459 — LIQUI-SERA SPINAL FLUID CONTROL (December 29, 1987)
  • K863849 — LIQUI-SERA COMBO LIGAND/TDM CONTROLS (November 24, 1986)
  • K853906 — LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (October 4, 1985)
  • K842668 — LIQUI-HEME HEMOGLOBIN CALIBRATORS (March 5, 1985)
  • K840618 — LIQUI-URA CHEMISTRY URINE CONTROLS (April 4, 1984)
  • K834398 — LIQUI-SERA TDM CALIBRATORS (February 3, 1984)
  • K834259 — LIQUI-URA TOXIC URINE CONTROL (January 30, 1984)
  • K831278 — LIQUI-SERA ANTICONVULSANTS CONTROLS (May 27, 1983)

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  • 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)