Glucose Analyzer 2 W/ Choles. Reag KT
FDA 510(k) K761136 · Beckman Instruments, Inc.
510(k) numberK761136
Submission
- Device name
- Glucose Analyzer 2 W/ Choles. Reag KT
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- November 24, 1976
- Decision date
- January 26, 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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Questions and answers
When was Glucose Analyzer 2 W/ Choles. Reag KT cleared by the FDA?
Glucose Analyzer 2 W/ Choles. Reag KT (K761136) received a 510(k) decision of Substantially Equivalent on January 26, 1977, 63 days after the submission was received.
What is the product code of K761136?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.