510(k) K862506

THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR by Millipore Corp. — Product Code KIE

K862506 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR". The FDA issued a decision of Substantially Equivalent on July 29, 1986. The device falls under product code KIE (Apparatus, High Pressure Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1986
Date Received
July 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, High Pressure Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type