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510(k) K051101

VERIFY FLASH INTEGRATOR by Albert Browne , Ltd. — Product Code JOJ

K051101 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "VERIFY FLASH INTEGRATOR". The FDA issued a decision of Substantially Equivalent on December 6, 2005. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Albert Browne , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2005
Date Received
April 29, 2005
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 Albert Browne , Ltd.

  • K063285 — RELIANCE CI PROCESS INDICATOR (January 12, 2007)
  • K061738 — ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD (August 25, 2006)
  • K053479 — VERIFY DRY HEAT LABEL (July 18, 2006)
  • K060066 — VERIFY 3-10 MIN FLASH INTEGRATOR (March 24, 2006)
  • K060103 — ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS (March 7, 2006)
  • K051056 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR (October 20, 2005)
  • K032801 — MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (October 17, 2003)
  • K002741 — BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK (July 3, 2002)
  • K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (November 5, 2001)
  • K012335 — BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS (October 1, 2001)

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)

FDA data resources