510(k) K011586
K011586 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Inc. for the device "IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE". The FDA issued a decision of Substantially Equivalent on November 16, 2001. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Diametrics Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2001
- Date Received
- May 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type