The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Enteric Parasite Panel, Bd Max Instrument.
| Device ID | K143648 |
| 510k Number | K143648 |
| Device Name: | BD MAX Enteric Parasite Panel, BD MAX Instrument |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | BECTON, DICKINSON AND COMPANY 7 LOVETON CIR. Sparks, MD 21152 |
| Contact | Paul Swift |
| Correspondent | Paul Swift BECTON, DICKINSON AND COMPANY 7 LOVETON CIR. Sparks, MD 21152 |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904433802 | K143648 | 000 |
| 00382904429607 | K143648 | 000 |