510(k) K932603
K932603 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "APOLIPOPROTIEN B (APO B)". The FDA issued a decision of Substantially Equivalent on Jun 2, 1994. The device falls under product code JHN (Turbidimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 1994
- Date Received
- May 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Turbidimetric Method, Lipoproteins
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type
- 510(k) Exempt