FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M Comply Hydrogen Peroxide Indicator Tape 1228
K Number: K150694
·
Decision Oct 1, 2015
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
331
Review Days
197
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Basic Information
- Device Name
- 3M Comply Hydrogen Peroxide Indicator Tape 1228
- K Number
- K150694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Company
- Date Received
- March 18, 2015
- Decision Date
- October 1, 2015
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | Jun 27, 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 |
| 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 |