510(k) K771586
K771586 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Methods, Inc. for the device "CHOLOPAP-HDL". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Advanced Biomedical Methods, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 1977
- Date Received
- August 18, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Esterase--Oxidase, Cholesterol
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- CH
- Submission Type