The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Enzyme Linked Umminoabsorbent Assay, Rubella.
| Device ID | K953826 |
| 510k Number | K953826 |
| Device Name: | ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA |
| Classification | Antisera, Cf, Rubella |
| 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 | GOM |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1995-12-14 |