3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
FDA 510(k) clearance K103277 · decided 2011-04-19
Clearance details
- K-number
- K103277
- Device name
- 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
- Applicant
- 3M Company-3M Health Care
- Decision
- Substantially Equivalent
- Date received
- 2010-11-05
- Decision date
- 2011-04-19
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biologi recall (Z-2002-2014) | 3M Company - Health Care Business | 2014-07-07 |