The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for B-hcg Human Serum Controls.
Device ID | K932479 |
510k Number | K932479 |
Device Name: | B-HCG HUMAN SERUM 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 Poretta |
Correspondent | Jeanette Poretta 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 | 1993-05-24 |
Decision Date | 1993-12-02 |