Home / 510(k) Clearances / K131029

510(k) K131029

ACCU-CHEK AVIVA PLUS TEST STRIP by Roche Diagnostics Operations, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2013
Date Received
April 12, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Roche Diagnostics Operations, Inc.

  • K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity (January 24, 2025)
  • K233454 — ONLINE TDM Methotrexate (February 20, 2024)
  • K163633 — cobas HbA1c Test, cobas b 101 system (July 28, 2017)
  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K121610 — COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY (August 8, 2013)
  • K113072 — TINA-QUANT ALBUMIN GEN.2 (May 14, 2012)

Other clearances for product code NBW

  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)