510(k) K073072
K073072 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B". The FDA issued a decision of Substantially Equivalent on February 21, 2008. The device falls under product code JHM (Colorimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2008
- Date Received
- October 31, 2007
- 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