Beckman Cholesterol Reagent
FDA 510(k) K934046 · Beckman-Diagnostic Systems Group
510(k) numberK934046
Submission
- Device name
- Beckman Cholesterol Reagent
- Applicant
- Beckman-Diagnostic Systems Group
Brea, CA, US - Received
- August 19, 1993
- Decision date
- October 28, 1993
- 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
Other 510(k)s with product code CHH
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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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| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | 12/12/1994SE |
| K944605 | CX Phencyclidine Reagent for Synschron CX SystemLCM · Traditional | 12/07/1994SE |
| K944604 | CX Amphetamines Reagent for Synchron CX SystemsDKZ · Traditional | 12/07/1994SE |
| K944606 | CX Opiate Reagent for Synchron CX SystemsDJG · Traditional | 11/30/1994SE |
| K942676 | Synchron CX3 DeltaJJF · Traditional | 11/02/1994SE |
| K934293 | Beckman Pancreatic Amylase (Pamy) ReagentJFJ · Traditional | 07/06/1994SE |
| K934068 | Beckman Direct Bilirubin ReagentCIG · Traditional | 04/26/1994SE |
| K936184 | Vigil PRX Chemistry ControlJJY · Traditional | 04/15/1994SE |
| K934271 | Beckman Synchron Lactate ReagentKHP · Traditional | 11/09/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | 10/27/1993SE |
Questions and answers
When was Beckman Cholesterol Reagent cleared by the FDA?
Beckman Cholesterol Reagent (K934046) received a 510(k) decision of Substantially Equivalent on October 28, 1993, 70 days after the submission was received.
What is the product code of K934046?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.