510(k) K030035
K030035 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Inc. for the device "IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE". The FDA issued a decision of Substantially Equivalent on June 25, 2003. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Diametrics Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2003
- Date Received
- January 3, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type