The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Refractometric, Total Protein.
Device ID | K933218 |
510k Number | K933218 |
Device Name: | REFRACTOMETRIC, TOTAL PROTEIN |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | PYRAMID BIOLOGICAL CORP. 6473 VAN NUYS Van Nuys, CA 91401 |
Contact | Jeanette R Porretta |
Correspondent | Jeanette R Porretta PYRAMID BIOLOGICAL CORP. 6473 VAN NUYS 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 | 1993-07-01 |
Decision Date | 1994-02-17 |