3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)— 510(k) K220942
Substantially Equivalent3M Company
FDA 510(k) clearance K220942 for 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES), Substantially Equivalent on 2022-06-24. 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
- Special
- Location
- St. Paul, MN, US
Recent devices under product code JOJ
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- 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 K220942
K-number listed on FDA's recall record- Z-1609-2023 — 3M Attest Steam Chemical Integrators, REF 1243A
- Z-1610-2023 — 3M Attest Steam Chemical Integrators, REF 1243B
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220942.
Data sourced from openFDA. This site is unofficial and independent of the FDA.