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510(k) K061738

ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD by Albert Browne , Ltd. — Product Code JOJ

K061738 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD". The FDA issued a decision of Substantially Equivalent on Aug 25, 2006. 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
Aug 25, 2006
Date Received
Jun 20, 2006
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 (Jan 12, 2007)
  • K053479 — VERIFY DRY HEAT LABEL (Jul 18, 2006)
  • K060066 — VERIFY 3-10 MIN FLASH INTEGRATOR (Mar 24, 2006)
  • K060103 — ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS (Mar 7, 2006)
  • K051101 — VERIFY FLASH INTEGRATOR (Dec 6, 2005)
  • K051056 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR (Oct 20, 2005)
  • K032801 — MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (Oct 17, 2003)
  • K002741 — BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK (Jul 3, 2002)
  • K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (Nov 5, 2001)
  • K012335 — BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS (Oct 1, 2001)

Other clearances for product code JOJ

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

FDA data resources