510(k) K060264
K060264 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)". The FDA issued a decision of Substantially Equivalent on Mar 8, 2006. The device falls under product code JIY (Photometric Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Dade Behring, Inc. has 342 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 8, 2006
- Date Received
- Feb 1, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Iron (Non-Heme)
- Device Class
- Class I
- Regulation Number
- 862.1410
- Review Panel
- CH
- Submission Type
- 510(k) Exempt