510(k) K823196
K823196 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "SPECIAL CONTROL SERUM FOR HDL-CHOLES". The FDA issued a decision of Substantially Equivalent on Nov 29, 1982. The device falls under product code JJK (Oncometer, Plasma, For Clinical Use), a Class I device regulated under 21 CFR 862.2720. Boehringer Mannheim Corp. has 339 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 29, 1982
- Date Received
- Oct 26, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Oncometer, Plasma, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2720
- Review Panel
- CH
- Submission Type
- 510(k) Exempt