510(k) K841890

VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY by Varian Assoc., Inc. — Product Code KZR

K841890 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY". The FDA issued a decision of Substantially Equivalent on June 14, 1984. The device falls under product code KZR (Chromatography (Liquid, Gel), Clinical Use), a Class I device regulated under 21 CFR 862.2260. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1984
Date Received
May 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography (Liquid, Gel), Clinical Use
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type