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510(k) K021607

RDI HS CRP CALIBRATOR SET by Reference Diagnostics, Inc. — Product Code JIT

K021607 is an FDA 510(k) premarket notification submitted by Reference Diagnostics, Inc. for the device "RDI HS CRP CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on June 27, 2002. 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
June 27, 2002
Date Received
May 16, 2002
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.

  • K053291 — FERRITIN CALIBRATOR SET, CATALOG NO. 8203 (March 13, 2006)
  • K053211 — RDI HSFERRITIN KIT (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)
  • K000783 — DIRECT TIBC CALIBRATOR (May 4, 2000)
  • 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)
  • 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)

FDA data resources