510(k) K945584
K945584 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "NOVA 16 ANALYZER". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use), a Class I device regulated under 21 CFR 862.2150. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1995
- Date Received
- November 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2150
- Review Panel
- CH
- Submission Type