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510(k) K963493

FERRITIN CALIBRATOR by Dade Chemistry Systems, Inc. — Product Code JIT

K963493 is an FDA 510(k) premarket notification submitted by Dade Chemistry Systems, Inc. for the device "FERRITIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 3, 1996. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Dade Chemistry Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1996
Date Received
September 3, 1996
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 Dade Chemistry Systems, Inc.

  • K973650 — TROPONIN (TROP) METHOD (October 20, 1997)
  • K973099 — PROSTATE SPECIFIC ANTIGEN CONTROL (September 29, 1997)
  • K973100 — PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (September 29, 1997)
  • K973101 — PROSTATE SPECIFIC ANTIGEN METHOD (September 18, 1997)
  • K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (April 28, 1997)
  • K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD (March 10, 1997)
  • K970393 — THYROID STIMULATING HORMONE METHOD (March 3, 1997)
  • K970336 — MMB CALIBRATOR (March 3, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K970389 — THYROID CALIBRATOR (February 18, 1997)

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)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163521 — Lumipulse G LH Calibrators (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)

FDA data resources