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510(k) K914958

RIATRAC PLUS by Becton Dickinson Advanced Diagnostics — Product Code JJY

K914958 is an FDA 510(k) premarket notification submitted by Becton Dickinson Advanced Diagnostics for the device "RIATRAC PLUS". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Becton Dickinson Advanced Diagnostics has at least 9 other 510(k) clearances on record.

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

Other clearances by Becton Dickinson Advanced Diagnostics

  • K935667 — QTEST(R) STREP (April 21, 1994)
  • K931294 — IQ TUPTAKE ASSAY (July 22, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926356 — PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG (March 18, 1993)
  • 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)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • 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)

FDA data resources