The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for Determiner Pl/determination Of Phospholipids.
| Device ID | K905829 |
| 510k Number | K905829 |
| Device Name: | DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS |
| Classification | Ammonium Molybdate And Ammonium Vanadate, Phospholipids |
| Applicant | KAMIYA BIOMEDICAL CO. P.O. BOX 6067 Thousand Oaks, CA 91359 |
| Contact | Mary Rees |
| Correspondent | Mary Rees KAMIYA BIOMEDICAL CO. P.O. BOX 6067 Thousand Oaks, CA 91359 |
| Product Code | CEL |
| CFR Regulation Number | 862.1575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-31 |
| Decision Date | 1991-01-30 |