510(k) K902935
K902935 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE COBAS READY HDL CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on September 27, 1990. The device falls under product code JHM (Colorimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1990
- Date Received
- July 3, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric Method, Lipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type