510(k) K940289
K940289 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "ABBOTT PRISM ANALYZER". The FDA issued a decision of Substantially Equivalent on July 18, 1994. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1994
- Date Received
- March 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2160
- Review Panel
- CH
- Submission Type