The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Serum Protein Controls.
| Device ID | K944515 |
| 510k Number | K944515 |
| Device Name: | SERUM PROTEIN CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1994-11-17 |