510(k) K890332
K890332 is an FDA 510(k) premarket notification submitted by Alpkem Corp. for the device "RFA/2 RAPID FLOW ANALYZER W/COMPUTER". The FDA issued a decision of Substantially Equivalent on February 17, 1989. 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. Alpkem Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- January 23, 1989
- 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