Ysi Model 1500 Blood Glucose Analyzer
FDA 510(k) K910633 · Yellow Springs Instrument Co., Inc.
510(k) numberK910633
Submission
- Device name
- Ysi Model 1500 Blood Glucose Analyzer
- Applicant
- Yellow Springs Instrument Co., Inc.
Yellow Springs, OH, US - Received
- February 13, 1991
- Decision date
- April 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K893409 | Ysi Models 4400 & 4700 Esophageal Stethoscope TempBZT · Traditional | 07/20/1989SE |
| K891480 | Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerCGA · Traditional | 05/22/1989SE |
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Questions and answers
When was Ysi Model 1500 Blood Glucose Analyzer cleared by the FDA?
Ysi Model 1500 Blood Glucose Analyzer (K910633) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 58 days after the submission was received.
What is the product code of K910633?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.