Corning 2500 Co-Oximeter
FDA 510(k) K830590 · Corning Medical & Scientific
510(k) numberK830590
Submission
- Device name
- Corning 2500 Co-Oximeter
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- February 24, 1983
- Decision date
- April 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHG – Whole Blood Hemoglobin Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
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| K994073 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 01/14/2000SE |
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| K953221 | Abbott Vision Hemoglobin (Modification)KHG · Traditional | Abbott Laboratories | 09/29/1995SE |
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| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | Biotrack, Inc. | 10/10/1989SE |
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Questions and answers
When was Corning 2500 Co-Oximeter cleared by the FDA?
Corning 2500 Co-Oximeter (K830590) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 40 days after the submission was received.
What is the product code of K830590?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.