3M IGG FASTLYME(TM) TEST— 510(k) K895713
Substantially Equivalent3M Company
FDA 510(k) clearance K895713 for 3M IGG FASTLYME(TM) TEST, Substantially Equivalent on 1990-12-14. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code LSR
view allMore 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.