Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose
FDA 510(k) K051376 · Roche Diagnostics
510(k) numberK051376
Submission
- Device name
- Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- May 26, 2005
- Decision date
- August 23, 2005
- 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
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Questions and answers
When was Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose cleared by the FDA?
Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose (K051376) received a 510(k) decision of Substantially Equivalent on August 23, 2005, 89 days after the submission was received.
What is the product code of K051376?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.