The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Syphilis Igm Human Serum Controls.
| Device ID | K961317 |
| 510k Number | K961317 |
| Device Name: | SYPHILIS IGM HUMAN SERUM CONTROLS |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys, CA 91401 |
| Contact | Jeanette R Poretta |
| Correspondent | Jeanette R Poretta PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys, CA 91401 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-05 |
| Decision Date | 1996-06-24 |