510(k) K884886
K884886 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "MODEL 250 LIQUID CHROMOTAGRAPHY PUMP". The FDA issued a decision of Substantially Equivalent on February 2, 1989. The device falls under product code LDM (Instrumentation, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1989
- Date Received
- November 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrumentation, High Pressure Liquid Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2260
- Review Panel
- TX
- Submission Type