510(k) K904031
K904031 is an FDA 510(k) premarket notification submitted by Texas Intl. Laboratories, Inc. for the device "CHEMA CHOL CHOLESTEROL SYSTEM". The FDA issued a decision of Substantially Equivalent on March 11, 1991. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Texas Intl. Laboratories, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1991
- Date Received
- August 31, 1990
- 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