The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Attest(tm) Super Rapid Readout Biological Indicator, 3m Attest(tm) Auto-reader.
| Device ID | K121484 |
| 510k Number | K121484 |
| Device Name: | 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Contact | Suzanne Leung |
| Correspondent | Suzanne Leung 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2012-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387762969 | K121484 | 000 |