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510(k) K000783

DIRECT TIBC CALIBRATOR by Reference Diagnostics, Inc. — Product Code JIT

K000783 is an FDA 510(k) premarket notification submitted by Reference Diagnostics, Inc. for the device "DIRECT TIBC CALIBRATOR". The FDA issued a decision of Substantially Equivalent on May 4, 2000. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Reference Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2000
Date Received
March 10, 2000
Clearance Type
Abbreviated
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 Reference Diagnostics, Inc.

  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)
  • K053291 — FERRITIN CALIBRATOR SET, CATALOG NO. 8203 (March 13, 2006)
  • K052148 — TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET (November 9, 2005)
  • K030044 — EXTENDED RANGE HS CRP KIT, CAT NO:9200 (September 30, 2003)
  • K030772 — RDI EXTENDED RANGE CRP CALIBRATOR SET (April 11, 2003)
  • K021609 — RDI HS CRP KIT (June 27, 2002)
  • K021607 — RDI HS CRP CALIBRATOR SET (June 27, 2002)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K990216 — MAGNETIC TIBC KIT (February 16, 1999)
  • K984107 — RDI DIRECT LDL CHOLESTEROL TEST (January 28, 1999)

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