Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips
FDA 510(k) K051213 · Abbott Laboratories, Inc.
510(k) numberK051213
Submission
- Device name
- Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips
- Applicant
- Abbott Laboratories, Inc.
Alameda, CA, US - Received
- May 12, 2005
- Decision date
- May 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
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Questions and answers
When was Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips cleared by the FDA?
Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips (K051213) received a 510(k) decision of Substantially Equivalent on May 27, 2005, 15 days after the submission was received.
What is the product code of K051213?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.