510(k) K821105
K821105 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "CHOLESTEZYME-V EIKEN". The FDA issued a decision of Substantially Equivalent on May 5, 1982. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1982
- Date Received
- April 20, 1982
- 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