Home / 510(k) Clearances / K170439

510(k) K170439

AN87 Dosimeter by Andersen Sterilizers, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2017
Date Received
February 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Andersen Sterilizers, Inc.

  • K213296 — Anprolene SteriTest RRBI (April 12, 2022)
  • K202879 — EOGas 4 Endo-SteriTest RRBI (March 3, 2021)
  • K192980 — EOGas 4 Endo-SteriTest (November 12, 2020)
  • K200334 — AN1036 Dosimeter (November 12, 2020)
  • K200336 — Tyvek Sterilization Pouches with Chevron Seal (November 12, 2020)
  • K200335 — Sterisheet Sterilization Wrap (November 12, 2020)
  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170437 — Sterisheet Sterilization Wrap (November 1, 2017)
  • K170427 — Anprolene SteriTest (October 31, 2017)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)

Other clearances for product code JOJ

  • K260181 — LF Process Indicator Tape for Steam Sterilization (February 20, 2026)
  • K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeS (December 23, 2025)
  • K251035 — DISINTEK™ PA Test Strips (June 3, 2025)
  • K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (May 2, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250172 — Green Card Bowie-Dick Test (BD115) (February 20, 2025)
  • K242860 — Type 5 Integrating Indicator for Steam (CSPN-15) (January 17, 2025)
  • K241036 — Autoclave Indicator Tape; EO Indicator Tape (December 17, 2024)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)
  • K242795 — Getinge Assured MI Steam Migrating Integrator (October 15, 2024)