FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M Attest Rapid Readout Biological Indicator, 1295
K Number: K211705
·
Decision Jun 28, 2022
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
202
Applicant Total
50
Review Days
390
Basic Information
- Device Name
- 3M Attest Rapid Readout Biological Indicator, 1295
- K Number
- K211705
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Company
- Date Received
- June 3, 2021
- Decision Date
- June 28, 2022
- Product Code
- FRC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by 3M Company
| K Number | Device Name | ||
|---|---|---|---|
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | Jan 28, 2025 | Substantially Equivalent |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | Nov 25, 2024 | Substantially Equivalent |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | Oct 18, 2024 | Substantially Equivalent |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | Sep 12, 2024 | Substantially Equivalent |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | Jun 27, 2024 | Substantially Equivalent |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | Jun 27, 2024 | Substantially Equivalent |
| DEN230068 | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 | May 21, 2024 | Unknown |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | Mar 15, 2024 | Substantially Equivalent |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | May 18, 2023 | Substantially Equivalent |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | Nov 1, 2022 | Substantially Equivalent |