510(k) K884886

MODEL 250 LIQUID CHROMOTAGRAPHY PUMP by The Perkin-Elmer Corp. — Product Code LDM

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