Astra Systems Cholesterol Reagent
FDA 510(k) K853854 · Beckman Instruments, Inc.
510(k) numberK853854
Submission
- Device name
- Astra Systems Cholesterol Reagent
- Applicant
- Beckman Instruments, Inc.
Fullerton, CA, US - Received
- September 16, 1985
- Decision date
- October 28, 1985
- 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
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| 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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Questions and answers
When was Astra Systems Cholesterol Reagent cleared by the FDA?
Astra Systems Cholesterol Reagent (K853854) received a 510(k) decision of Substantially Equivalent on October 28, 1985, 42 days after the submission was received.
What is the product code of K853854?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.