510(k) K800453
K800453 is an FDA 510(k) premarket notification submitted by Photovolt Corp. for the device "PHOTOVOLT PVA 4M+2 ANALYZER". The FDA issued a decision of Substantially Equivalent on March 20, 1980. 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. Photovolt Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 1980
- Date Received
- February 29, 1980
- 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