510(k) K901410
K901410 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON RA-2000(TM) SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 17, 1990. 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. Technicon Instruments Corp. has 156 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 17, 1990
- Date Received
- Mar 26, 1990
- 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
- 510(k) Exempt