510(k) K813077
K813077 is an FDA 510(k) premarket notification submitted by Technicon Corp. for the device "TECHNICON RA 1000 SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 1981. 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 Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1981
- Date Received
- November 2, 1981
- 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