510(k) K831813
K831813 is an FDA 510(k) premarket notification submitted by United Diagnostics, Inc. for the device "CO-OXIMETER CONTROL". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. United Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1983
- Date Received
- June 6, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Blood Hemoglobin Determination
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type