The following data is part of a premarket notification filed by Applied Biocode, Inc. with the FDA for Biocode Respiratory Pathogen Panel (rpp).
| Device ID | K192485 |
| 510k Number | K192485 |
| Device Name: | BioCode Respiratory Pathogen Panel (RPP) |
| Classification | Respiratory Virus Panel Nucleic Acid 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 | OCC |
| Subsequent Product Code | NSU |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOU |
| Subsequent Product Code | OTG |
| Subsequent Product Code | OZE |
| Subsequent Product Code | OZX |
| Subsequent Product Code | OZY |
| Subsequent Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-10 |
| Decision Date | 2019-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851034007073 | K192485 | 000 |