3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM— 510(k) K101528
Substantially Equivalent3M Company
FDA 510(k) clearance K101528 for 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM, Substantially Equivalent on 2010-10-01. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code JOJ
view all- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more
- K251035 — DISINTEK PA Test Strips
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
More clearances from 3M Company
view all- K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE +3 more
- K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more
- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Recalls naming K101528
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101528.
Data sourced from openFDA. This site is unofficial and independent of the FDA.