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 |