510(k) K832197

PRP-1 REVERSED PHASE RESIN by Hamilton Co. — Product Code DMZ

K832197 is an FDA 510(k) premarket notification submitted by Hamilton Co. for the device "PRP-1 REVERSED PHASE RESIN". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code DMZ (Liquid Chromatography, Adsorbent), a Class I device regulated under 21 CFR 862.2260. Hamilton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liquid Chromatography, Adsorbent
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type