The following data is part of a premarket notification filed by Applied Biocode, Inc. with the FDA for Biocode Gastrointestinal Pathogen Panel (gpp).
| Device ID | K180041 |
| 510k Number | K180041 |
| Device Name: | BioCode Gastrointestinal Pathogen Panel (GPP) |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs, CA 90670 |
| Contact | Robert Di Tullio |
| Correspondent | Robert Di Tullio Applied Biocode, Inc. 10020 Pioneer Blvd. Suite 102 Santa Fe Springs, CA 90670 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-05 |
| Decision Date | 2018-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851034007011 | K180041 | 000 |
| 00851034007004 | K180041 | 000 |