510(k) K831618
K831618 is an FDA 510(k) premarket notification submitted by Omega Medical Diagnostics for the device "HEMOGLOBIN REAGENT". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Omega Medical Diagnostics has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1983
- Date Received
- May 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Hemoglobin, Automated
- Device Class
- Class II
- Regulation Number
- 864.5620
- Review Panel
- HE
- Submission Type