510(k) K842522
K842522 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "PDA SYSTEM". The FDA issued a decision of Substantially Equivalent on August 2, 1984. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1984
- Date Received
- June 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Centrifugal, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2140
- Review Panel
- CH
- Submission Type