Cobas Reagent for Cholesterol
FDA 510(k) K801296 · Roche Analytical Instruments, Inc.
510(k) numberK801296
Submission
- Device name
- Cobas Reagent for Cholesterol
- Applicant
- Roche Analytical Instruments, Inc.
Mchenry, IL, US - Received
- June 2, 1980
- Decision date
- June 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Axis-Shield Poc AS
| 510(k) | Device | Decision |
|---|---|---|
| K801299 | Cobas Ck-Nac ReagentCGS · Traditional | 07/14/1980SE |
| K801298 | Cobas Reagent for Triglycerides & CobasCDT · Traditional | 07/08/1980SE |
| K801295 | Cobas Reagent for A-AmylaseJFJ · Traditional | 07/08/1980SE |
| K801297 | Cobas Reagent for Glucose RapidCFR · Traditional | 06/30/1980SE |
| K801243 | Cobas Reagents for Uric AcidCDO · Traditional | 06/26/1980SE |
| K801242 | Cobas Reagent for Alkaline PhosphataseCJE · Traditional | 06/20/1980SE |
| K801118 | Cobas Reagent for Ast (Sgot)CIT · Traditional | 06/20/1980SE |
| K801116 | Cobas Reagent for BunCDQ · Traditional | 06/17/1980SE |
| K801119 | Cobas Reagent for Alt (GPT)CKA · Traditional | 06/09/1980SE |
| K801117 | Cobas Total Bilirubin Reagent & DiluentCIG · Traditional | 06/09/1980SE |
Questions and answers
When was Cobas Reagent for Cholesterol cleared by the FDA?
Cobas Reagent for Cholesterol (K801296) received a 510(k) decision of Substantially Equivalent on June 30, 1980, 28 days after the submission was received.
What is the product code of K801296?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.