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 |