510(k) K791143
K791143 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "SICKLE-CELL F TEST". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code KQI (Assay, Fetal Hemoglobin), a Class II device regulated under 21 CFR 864.7455. Isolab, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1979
- Date Received
- June 18, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Fetal Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7455
- Review Panel
- HE
- Submission Type