Multistat III Cholesterol Test
FDA 510(k) K771508 · Instrumentation Laboratory CO
510(k) numberK771508
Submission
- Device name
- Multistat III Cholesterol Test
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- August 5, 1977
- Decision date
- September 13, 1977
- 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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| 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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Questions and answers
When was Multistat III Cholesterol Test cleared by the FDA?
Multistat III Cholesterol Test (K771508) received a 510(k) decision of Substantially Equivalent on September 13, 1977, 39 days after the submission was received.
What is the product code of K771508?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.