The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for H.pylori Controls.
| Device ID | K964675 |
| 510k Number | K964675 |
| Device Name: | H.PYLORI CONTROLS |
| Classification | Helicobacter Pylori |
| Applicant | PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys, CA 91401 |
| Contact | Jeanette R Porretta |
| Correspondent | Jeanette R Porretta PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys, CA 91401 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-21 |
| Decision Date | 1997-01-27 |