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510(k) K914958

RIATRAC PLUS by Becton Dickinson Advanced Diagnostics — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
November 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K925132 — BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE (December 28, 1992)
  • K923673 — PRECISE STREP A (September 28, 1992)
  • K923060 — IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (September 15, 1992)
  • K915197 — PRECISE TM HCG (December 17, 1991)
  • K915200 — PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (December 16, 1991)

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  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)