The following data is part of a premarket notification filed by Bacterioscan, Inc. with the FDA for Bacterioscan 216dx System.
| Device ID | K172412 |
| 510k Number | K172412 |
| Device Name: | BacterioScan 216Dx System |
| Classification | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture |
| Applicant | BacterioScan, Inc. 4041 Forest Park Ave. St. Louis, MO 63108 |
| Contact | Rhonda Soest |
| Correspondent | Fran White MDC Associates, LLC. 180 Cabot Street Beverly, MA 01915 |
| Product Code | QBQ |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2018-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B9090010 | K172412 | 000 |
| B90900522 | K172412 | 000 |
| B90900511 | K172412 | 000 |
| B9090050 | K172412 | 000 |
| B9090020 | K172412 | 000 |