Glucometer Encore Blood Glucose Test Strips
FDA 510(k) K964004 · Bayer Corp.
510(k) numberK964004
Submission
- Device name
- Glucometer Encore Blood Glucose Test Strips
- Applicant
- Bayer Corp.
Elkhart, IN, US - Received
- October 7, 1996
- Decision date
- February 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Glucometer Encore Blood Glucose Test Strips cleared by the FDA?
Glucometer Encore Blood Glucose Test Strips (K964004) received a 510(k) decision of Substantially Equivalent on February 10, 1997, 126 days after the submission was received.
What is the product code of K964004?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.