One Touch Ultra Blood Glucose Monitoring System
FDA 510(k) K002134 · Selfcare, Inc.
510(k) numberK002134
Submission
- Device name
- One Touch Ultra Blood Glucose Monitoring System
- Applicant
- Selfcare, Inc.
Waltham, MA, US - Received
- July 14, 2000
- Decision date
- August 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | 10/12/2000SE |
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| K001427 | Modification to Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 06/02/2000SE |
| K000583 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 03/17/2000SE |
| K993632 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 11/12/1999SE |
| K991480 | Excel GE Blood Glucose Test Strips & Code StripCGA · Traditional | 09/17/1999SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | 05/25/1999SE |
| K990939 | Fasttake Compact Blood Glucose Monitoring SystemCGA · Special | 04/20/1999SE |
| K983468 | Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional | 12/17/1998SE |
Questions and answers
When was One Touch Ultra Blood Glucose Monitoring System cleared by the FDA?
One Touch Ultra Blood Glucose Monitoring System (K002134) received a 510(k) decision of Substantially Equivalent on August 7, 2000, 24 days after the submission was received.
What is the product code of K002134?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.