510(k) K991727
K991727 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STAT PROFILE M7 ANALYZER". The FDA issued a decision of Substantially Equivalent on July 16, 1999. The device falls under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine), a Class II device regulated under 21 CFR 862.1225. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1999
- Date Received
- May 20, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Based, Enzymatic, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type