Biotrol Cholesterol Enzymatique Color
FDA 510(k) K872930 · Biotrol, USA, Inc.
510(k) numberK872930
Submission
- Device name
- Biotrol Cholesterol Enzymatique Color
- Applicant
- Biotrol, USA, Inc.
Berwyn, PA, US - Received
- July 27, 1987
- Decision date
- August 21, 1987
- 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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| K934014 | Vacusol Plus Dental Vacuum Line Cleaner/DisinfectantLRJ · Traditional | 12/06/1995SE |
| K931141 | Biotrol Amylase CNPG3CIJ · Traditional | 05/26/1993SE |
| K921855 | Biotrol Bicarbonate StandardsJIS · Traditional | 08/03/1992SE |
| K921677 | Biotrol Magnesium (Magon)JGJ · Traditional | 05/26/1992SE |
| K912795 | Biotrol Uibc ReagentJMO · Traditional | 08/12/1991SE |
| K910721 | Biotrol Protein Multilevel StandardsJIS · Traditional | 05/06/1991SE |
| K905683 | Biotrol Lactate Dehydrogenase (L-P)CFJ · Traditional | 03/11/1991SE |
| K905280 | Biotrol Bilirubin C & T ControlJJX · Traditional | 02/04/1991SE |
| K894544 | Biotrol Rub-E.I.A. Test GLFX · Traditional | 08/30/1989SE |
| K891061 | Biotrol Calcium MonoreactifCJY · Traditional | 08/10/1989SE |
Questions and answers
When was Biotrol Cholesterol Enzymatique Color cleared by the FDA?
Biotrol Cholesterol Enzymatique Color (K872930) received a 510(k) decision of Substantially Equivalent on August 21, 1987, 25 days after the submission was received.
What is the product code of K872930?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.