510(k) K914432
K914432 is an FDA 510(k) premarket notification submitted by Chemtrak, Inc. for the device "ACCUMETER(R) CHOLESTEROL SELF-TEST". The FDA issued a decision of Substantially Equivalent on March 2, 1993. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Chemtrak, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1993
- Date Received
- October 4, 1991
- 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