The following data is part of a premarket notification filed by Otsuka Pharmaceutical Co., Ltd. with the FDA for Rlp-cholesterol Immunoseparation Assay.
| Device ID | K001032 |
| 510k Number | K001032 |
| Device Name: | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | OTSUKA PHARMACEUTICAL CO., LTD. 2440 RESEARCH BLVD. Rockville, MD 20850 |
| Contact | James W Harris |
| Correspondent | James W Harris OTSUKA PHARMACEUTICAL CO., LTD. 2440 RESEARCH BLVD. Rockville, MD 20850 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-30 |
| Decision Date | 2000-07-24 |