510(k) K771093
K771093 is an FDA 510(k) premarket notification submitted by Harleco for the device "UNIPAK CHOLESTEROL". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code CGO (Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1977
- Date Received
- June 16, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- CH
- Submission Type