Lifescan Surestep Blood Glucose Monitoring System
FDA 510(k) K942455 · Lifescan, Inc.
510(k) numberK942455
Submission
- Device name
- Lifescan Surestep Blood Glucose Monitoring System
- Applicant
- Lifescan, Inc.
Milpitas, CA, US - Received
- May 23, 1994
- Decision date
- March 24, 1995
- 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 Lifescan Surestep Blood Glucose Monitoring System cleared by the FDA?
Lifescan Surestep Blood Glucose Monitoring System (K942455) received a 510(k) decision of Substantially Equivalent on March 24, 1995, 305 days after the submission was received.
What is the product code of K942455?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.