Precision Point of Care Blood Glucose Test Strip with True Measure Technology
FDA 510(k) K021960 · Abbott Laboratories
510(k) numberK021960
Submission
- Device name
- Precision Point of Care Blood Glucose Test Strip with True Measure Technology
- Applicant
- Abbott Laboratories
Bedford, MA, US - Received
- June 14, 2002
- Decision date
- August 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | Hmd Biomedical, Inc. | 02/14/2013SE |
| K122435 | Nova One Blood Glucose MonitorLFR · Traditional | Nova Biomedical Corporation | 12/20/2012SE |
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| K121224 | Genesis Health Technologies Blood Glucose Monitoring SystemLFR · Special | Taidoc Technology Corporation | 09/19/2012SE |
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Questions and answers
When was Precision Point of Care Blood Glucose Test Strip with True Measure Technology cleared by the FDA?
Precision Point of Care Blood Glucose Test Strip with True Measure Technology (K021960) received a 510(k) decision of Substantially Equivalent on August 16, 2002, 63 days after the submission was received.
What is the product code of K021960?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.