510(k) K964660
K964660 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "PARAMAX CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 4, 1997. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Dade Intl., Inc. has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 4, 1997
- Date Received
- Nov 20, 1996
- 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
- 510(k) Exempt