510(k) K771090
K771090 is an FDA 510(k) premarket notification submitted by Harleco for the device "UNIPAK HEMOGLOBIN". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1977
- Date Received
- June 16, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cyanomethemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type