RLP Cholesterol Immunoseparation Assay
FDA 510(k) K991083 · Otsuka Pharmaceutical Co., Ltd.
510(k) numberK991083
Submission
- Device name
- RLP Cholesterol Immunoseparation Assay
- Applicant
- Otsuka Pharmaceutical Co., Ltd.
Rockville, MD, US - Received
- March 31, 1999
- Decision date
- August 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
| K181373 | Extended Lipid Panel AssayCHH · Traditional | Laboratory Corporation of America Holdings | 10/18/2018SE |
| K180504 | Mission Lipid Panel Monitoring SystemCHH · Special | ACON Laboratories, Inc. | 03/28/2018SE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
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| 510(k) | Device | Decision |
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| K092817 | POC-AS10 Auto SamplerMSQ · Traditional | 03/09/2010SE |
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| K041148 | Pocone Infrared SpectrophotometerMSQ · Traditional | 07/15/2004SE |
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | 12/21/2001SE |
| K001032 | Rlp-Cholesterol Immunoseparation AssayCHH · Traditional | 07/24/2000SE |
Questions and answers
When was RLP Cholesterol Immunoseparation Assay cleared by the FDA?
RLP Cholesterol Immunoseparation Assay (K991083) received a 510(k) decision of Substantially Equivalent on August 20, 1999, 142 days after the submission was received.
What is the product code of K991083?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.