510(k) K984191
K984191 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "MYOGLOBIN FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on December 10, 1998. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1998
- Date Received
- November 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Myoglobin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5680
- Review Panel
- IM
- Submission Type