Accu-Chek Instant Plus G-C/Dm Blood Glucose Monitoring System
FDA 510(k) K944459 · Boehringer Mannheim Corp.
510(k) numberK944459
Submission
- Device name
- Accu-Chek Instant Plus G-C/Dm Blood Glucose Monitoring System
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- September 12, 1994
- Decision date
- April 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Accu-Chek Instant Plus G-C/Dm Blood Glucose Monitoring System cleared by the FDA?
Accu-Chek Instant Plus G-C/Dm Blood Glucose Monitoring System (K944459) received a 510(k) decision of Substantially Equivalent on April 17, 1996, 583 days after the submission was received.
What is the product code of K944459?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.