510(k) K883020
K883020 is an FDA 510(k) premarket notification submitted by Alpkem Corp. for the device "RFA-300 RAPID FLOW ANALYZER W/COMPUTER". The FDA issued a decision of Substantially Equivalent on September 2, 1988. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170. Alpkem Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1988
- Date Received
- July 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Micro, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2170
- Review Panel
- CH
- Submission Type